Effects of Rice Bran Arabinoxylan Compound on Quality of Life of Cancer Patients During Active Treatment: A Randomised Placebo-controlled Pilot Trial

Effects of Rice Bran Arabinoxylan Compound on Quality of Life of Cancer Patients During Active Treatment: A Randomised Placebo-controlled Pilot Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Effects of Rice Bran Arabinoxylan Compound on Quality of Life of Cancer Patients During Active Treatment: A Randomised Placebo-controlled Pilot Trial Soo Liang Ooi, Peter S Micalos, Robert Zielinski, Judith Lacey, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5837950/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 02 Mar, 2026 Read the published version in Scientific Reports → Version 1 posted 12 You are reading this latest preprint version Abstract Background: The effects of a plant-based immunomodulator, rice bran arabinoxylan compound (RBAC), on the quality of life (QoL) of cancer patients during active treatment are unclear. Methods: The RBAC-QoL study was a randomised, placebo-controlled, double-blind feasibility study to address the role of RBAC in cancer patients receiving systemic therapies. The primary outcome measure was patient-reported functional, symptom, and global QoL scores. Secondary and exploratory outcome measures included nutritional indices and cytokine changes. Adult patients ( n = 29) with solid organ tumours (≥ stage II) undergoing systemic treatment were recruited from outpatient centres in New South Wales, Australia. Group allocation was assigned through stratified randomisation (RBAC = 12, placebo = 17). Interventions were either RBAC or matched placebo at 3g/day for 24 weeks. The participants, oncologists, and data collectors were blinded. Data were collected from five study visits, six weeks apart. An intention-to-treat analysis was performed using repeated measure ANOVA with pairwise comparisons where statistical significance was observed. Data sets not conforming to normality were tested with nonparametric ANOVA-type statistics. Results: The global QoL scores differed significantly between groups with a large effect size ( p = 0.031, eta 2 [g] = 0.147). Pairwise comparisons found significant differences favouring the RBAC group at week 6 ( p = 0.017, Cohen’s d = 1.119) and week 24 ( p = 0.041, d = 0.970). Compared to the placebo group, the RBAC group showed significantly better role ( p < 0.001) and social ( p = 0.037) functioning, while the cognitive functioning score difference was trending higher ( p = 0.055). Regarding cancer symptoms, the placebo group reported significantly worse scores ( p < 0.05) in fatigue, pain, dyspnoea, and appetite loss compared to the RBAC group. Significant elevations ( p < 0.05) of cytokine interferon-γ, interleukin 1RA and 12p40, as well as total protein, were also detected in the RBAC group compared to placebo over time. These serum markers correlated positively with the global QoL scores, indicating potential interactions of immune activity, nutritional status, and QoL. No intervention-related adverse events were reported in both groups. Conclusions: RBAC improves QoL beyond placebo during systemic cancer treatment, potentially through the immuno-nutritional pathway. Trial registration: Prospective registration on the Australian New Zealand Clinical Trials Registry (ANZCTR Reg No: ACTRN12619000562178p, 10/04/2019). Biological sciences/Immunology/Translational immunology Health sciences/Health care/Quality of life Biobran Biological response modifier Natural compound Polysaccharide Immunomodulator Immunotherapy Chemotherapy Symptom management Supportive care Patient-reported outcome measures Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Background Cancer is a global health concern. According to the Global Cancer Observatory data released by the International Agency for Research on Cancer, there were close to 20 million new cancer cases worldwide in 2022 and the disease caused approximately 9.7 million deaths (1). At this rate, nearly one in five people in the world will develop cancer in their lifetime (2). Survival is the primary outcome of concern in cancer therapies (3). Cytotoxic agents, including newer targeted therapies and immunotherapies, surgery and radiotherapy, are routinely used to eradicate malignant cells (4). Their administration also significantly affects healthy tissues and causes unwanted and common side effects such as nausea, vomiting, diarrhoea, appetite loss, peripheral neuropathy, fatigue and many others (5). As a result, cancer treatment can be physically and emotionally challenging for the patients, affecting them socially and financially. Cancer and its treatment could have long-term impacts on patients. With improvements in therapeutics coupled with early detection, people are now living longer after cancer diagnosis (6). Hence, there is a growing focus on the importance of supportive care rather than merely on cancer cure. The quality of life (QoL) outcome of cancer patients becomes a crucial clinical consideration (3, 7, 8). Improving the QoL of patients through complementary and supportive treatments has been suggested to enhance overall well-being and disease outcomes (9, 10). Rice bran arabinoxylan compound (RBAC) is a plant-based immunomodulator that has exhibited anticancer properties in research and demonstrated immune restorative function in cancer patients clinically by upregulating natural killer (NK) cell activity and enhancing inflammatory and cytotoxic responses (11). Previous reviews by the lead author (11, 12) found evidence showing RBAC as a complementary therapy used with conventional cancer treatment, which enhanced the immune profile, especially in boosting the NK cell activity, reduced treatment side effects, improved treatment outcomes and survival rates. RBAC was hypothesised to impact the QoL of cancer patients by improving immune function and lowering systemic inflammation, leading to reducing treatment toxicity, symptom severity, and behavioural comorbidities while enhancing the nutritional status and physical functioning (13). However, there is a lack of well-designed clinical trials assessing the impact of RBAC supplementation on the QoL of cancer patients using validated QoL instruments (11, 12). The present pilot study was conducted to obtain preliminary data for informing the design of a future large-scale clinical trial. This study utilises an internationally validated questionnaire, the European Organisation for the Research and Treatment of Cancer (EORTC) core 30-item QoL questionnaire (QLQ-C30), to determine the potential effects of RBAC compared with placebo on the QoL of cancer patients undergoing active anticancer treatment of either chemotherapy or immunotherapy. Secondary objectives were to ascertain potential associations between RBAC intervention, nutritional, and immune markers as possible mechanisms influencing the QoL of the patients. Methods Trial design The RBAC-QoL study was a randomised, placebo-controlled trial consisting of two parallel groups with a 1:1 allocation ratio. Before recruitment, the trial was approved by the Human Research Ethics Committee (HREC) of Concord Repatriation General Hospital, Sydney Local Health District (Application No. 2019/ ETH00489) and the Charles Sturt University HREC (Protocol No. H19244). The trial was also registered with the Australian New Zealand Clinical Trials Registry (ANZCTR Reg No: ACTRN12619000562178p; First registration on 10/04/2019). The study protocol was available for open access (14). A report documenting the approved protocol variations, statistical methods, and interim analysis has also been published (15). Readers are encouraged to refer to the earlier publications for further details. All methods were carried out in accordance with the principles, regulations, governance and guidelines for conducting clinical trials based on the National Clinical Trial Governance Framework of Australia (16). This report adheres to the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines (17). Eligibility criteria The inclusion criteria were adult patients (≥ 18 years old) diagnosed with any solid organ cancer (≥ stage II) and undergoing chemotherapy or immunotherapy treatment at participating outpatient cancer centres while maintaining adequate bone marrow, liver, and kidney functions. The exclusion criteria were those with existing mental health conditions that might impede the ability to provide consent or those not able to complete the QoL questionnaire with minimal assistance; female patients who were pregnant, lactating, or planned to get pregnant during the period of the study; and anyone with active or prior documented autoimmune or inflammatory disorders (except autoimmune vitiligo or alopecia, stable hypothyroidism on hormone replacement, and any chronic skin condition that did not require systemic therapy) within the last five years. Participants Participants were recruited from four outpatient cancer centres in New South Wales, Australia, through doctor referrals or on-site advertising. Interested patients were provided with trial information by study coordinators trained in Good Clinical Practice. These potential participants were given at least 24 hours for consideration and informed discussions with their doctors and family members. The study coordinator would follow up with the patients for clarification and obtain written consent from willing participants under the supervision of the principal investigator on site. Participants were screened for eligibility before enrolment. Interventions The participant took either RBAC or a placebo powder (dissolved in water) as an oral supplement (3g/day) for 24 weeks. Daiwa Pharmaceutical Co., Ltd. (Japan) manufactured and supplied the intervention packs in plastic sachets identical in appearance, containing RBAC or placebo powder with similar colour, odour, and taste. Further details on the RBAC and placebo used in this study were documented in the study protocol (14). All participants continued their oncological treatment during the trial and were required to attend five study visits, spaced six weeks apart, to provide data and undergo blood tests (total duration: 24 weeks). Outcomes The primary outcome measure was self-reported QoL based on the QLQ-C30. Participants completed QLQ-C30 either on paper or electronically. Approval for QLQ-C30 use for research was obtained prior to study initiation. The scoring of QLQ-C30 followed the procedures stipulated by EORTC (18) with a global QoL scale, five functional scales (physical, role, emotional, cognitive, and social), and nine symptom-related measures (fatigue, nausea & vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) plus a financial difficulties item. Each scale/item was an outcome variable for analysis to determine the most appropriate primary measures that best reflect any potential effect of RBAC compared to placebo on the QoL of cancer patients. The secondary outcome measures of this study included body composition parameters (body weight, body fat ratio, and muscle mass), body mass index (BMI), and biochemical indices for nutritional assessment based on immunological and inflammatory markers. These nutritional status indices were the neutrophil-to-lymphocyte ratio (NLR) and the inflammatory-nutritional index (INI = the ratio of C-reactive protein and albumin). Fifteen human cytokine/chemokine markers, including granulocyte-macrophage colony-stimulating factor, interferon-gamma (IFN-γ), interleukin (IL)-1β, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p40, IL-12p70, IL-13, monocyte chemoattractant protein-1, and tumour necrosis factor-alpha (TNF-α), were analysed using multiplex quantification via Luminex xMAP technology (Luminex, Austin, TX, USA) to explore the immunomodulating effects of RBAC. The multiplexing analysis was conducted by Eve Technologies Corp. (Calgary, AB, Canada). Further details on the collection, storage, and analysis of the biological samples can be found in earlier publications (14, 15). Patient safety was assessed with routine blood tests during cancer treatment, including complete blood count, liver function, electrolytes, urea, creatinine, and prealbumin. Adverse events reported by participants during clinical visits throughout the trial were also tracked and documented based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Data on the participants’ lifestyle factors were also collected using the Australian Eating Survey (AES) for dietary quality (19), the International Physical Activity Questionnaire (IPAQ) for physical activeness (20), and custom-designed Use of Complementary and Alternative Medicine Questionnaire (CAMQ) for usage and perceived value of complementary therapies (14). These lifestyle factors were assessed as potential confounding factors that might affect QoL. For more details on these lifestyle assessment questionnaires and the scoring methods, please refer to the study protocol (14) and interim analysis (15). The present study also included analysis of microbiota diversity (alpha diversity) and composition of different gut bacteria groups (beta diversity) between the RBAC and placebo groups as exploratory outcomes. The methods and results of faecal microbiome analysis based on 16S ribosomal RNA gene sequencing are complex and will be reported in a separate publication. Sample size The recruitment target was 50 participants with equal distribution in two groups. This sample size calculation was based on analysis of variance (ANOVA) with two groups and five repeated measures (RM), using a priori parameters with an alpha of 0.05, a power of 0.8, and an effect size of 0.35, resulting in a total sample size of 42. The effect size estimate of 0.35 was used according to the guidelines for sample size calculations for QLQ-C30 scores (21). The recruitment target was also consistent with sample size recommendations for a pilot study, as mentioned in the protocol (14). Randomisation Consented participants were screened based on the eligibility criteria before being randomly assigned to take either the RBAC or placebo intervention. The random allocation sequence was computer-generated using a stratified algorithm taking metastatic status (yes or no) and treatment (chemotherapy or immunotherapy) as inputs. The random allocation was done remotely by a researcher who did not interact with the participants. The patient, the treating oncologist, and the study coordinator were blinded to the actual content of the study intervention. Statistical methods Datasets were analysed with RStudio version 2024.09.0 Build 375 (Posit, Boston, MA, USA), running R version 4.4.0. Data analysis was based on the intention-to-treat principle. Every data point collected from participants in the trial was used regardless of withdrawal. Between-group comparisons over different time points were analysed with RM ANOVA. The F statistics with degrees of freedom, p -value, and the effect size (generalised eta 2 ) were reported for significant outcomes after sphericity correction. Values of eta 2 were interpreted as small (eta 2 ≥ 0.01), medium (eta 2 ≥ 0.06), and large (eta 2 ≥ 0.14) effects. Pairwise comparisons were conducted when statistical significance was observed with the false discovery rates applied to adjust the p -values for multiple comparisons. The effect sizes of the pairwise comparisons in Cohen’s d were also reported and interpreted as small ( d ≥ 0.2), medium ( d ≥ 0.5), and large ( d ≥ 0.8). Pearson’s correlation coefficient ( r ) was used to detect the strengths and directions of the relationships among the significant outcome variables. The strength of the r -coefficient was interpreted as non-significant ( r < 0.2), weak (0.2 ≥ r < 0.4), moderate (0.4 ≥ r < 0.6), strong (0.6 ≥ r < 0.8), and very strong ( r ≥ 0.8). Outcome measures with data not conforming to normality were tested using nonparametric tests with ANOVA-type statistics utilising the npartLD R software package (22). Significance was based on the p -value of the modified ANOVA-type statistic (mATS) after considering the whole-plot factors. The values of mATS with degrees of freedom and p -values were reported, and the relative treatment effects (RTE) of both groups were compared at each visit for significant outcomes. RTE is a descriptive point estimator of the intervention effects under the rank-based nonparametric methods introduced by Brunner and Puri (23). Between-group comparisons were analysed for baseline characteristics and adverse events. Continuous variables were reported as mean ± standard deviation. The difference between any two means was analysed using two-sided Student’s t-statistics. Fisher’s exact test was used to determine if there were nonrandom associations between two categorical variables. A p -value of less than or equal to 0.05 was considered statistically significant. If there were any significant between-group differences in the baseline characteristics or lifestyle factors, covariance analysis (ANCOVA) was to be performed on the significant outcomes in the primary analysis. The estimated marginal means of the outcome variables were calculated to adjust for any significant impact of the differences in baseline parameters, followed by pairwise comparisons to predict the differences after considering all confounding factors. Results Recruitment flow Recruitment was conducted from June 2020 to December 2023, with interruptions during the COVID-19 pandemic. Follow-up with the last participant was completed in April 2024. The trial concluded short of the recruitment target due to resource and financial constraints. The participant flow report is presented in a CONSORT flowchart (24), depicted in Figure 1. During recruitment, 62 potential participants from four study sites were identified. Thirty-six of them consented to participate and were screened for eligibility. Five did not meet the eligibility criteria, and one decided not to proceed with the trial after screening. The remaining 30 participants were randomly assigned to the two intervention groups (RBAC = 12, placebo = 18). Runs test for randomness (Wald-Wolfowitz test⁠) on the allocation sequence yielded a p -value of 0.441, indicating that the group allocation was random. After randomisation, three participants withdrew their consent without receiving the allocated intervention. Two were from the placebo group, and one was from the RBAC group. Reasons for early withdrawal included physical injury, palliative care, and not being able to cope with additional tasks during cancer treatment. During follow-up, one participant from the RBAC group dropped out due to rapidly progressing cancer and passed away two weeks into the trial. In contrast, seven participants from the placebo group discontinued the intervention. Their withdrawals resulted primarily from not being able to cope with protocol activities due to the side effects of conventional cancer treatment ( n = 5). One patient was not responsive to standard immunotherapy and was placed on an experimental treatment, which precluded participation in any other trial. Another participant went into palliative care and passed away subsequently. Hence, 19 participants fully completed the trial: 10 in the RBAC group and 9 in the placebo group. Overall, among those who completed the trial, the compliance rate was high, averaging 99%, indicating the ease of consuming the oral supplements. All participants with at least some data collected were included in the intention-to-treat analysis. Only one participant from the placebo group was omitted, as the participant withdrew before providing any baseline data. Thus, data from 29 participants (RBAC = 12, placebo = 17) were analysed for the primary outcome. Participant characteristics The characteristics of both groups are shown in Table 1, comparing age, sex, body composition, cancer type, cancer stage, recurrence, metastasis, treatment type, lifestyle factors, and trial status. No significant differences were detected between the groups in baseline characteristics. Although the withdrawal rate appears higher in the placebo group (41.2%) than in the RBAC group (8.3%), the difference in frequency distribution did not reach statistical significance. Primary outcome analysis The global QoL scale (QL2) was analysed with RM ANOVA and showed statistical differences between groups (F[1,15] = 5.67, p = 0.031, eta 2 [g] = 0.147). However, the effects of time and the interaction between time and group were not statistically significant. Pairwise comparisons of mean QL2 between groups for each time point are shown in Table 2. Clinically and statistically significant differences were observed at week 6 and week 24 with large effect sizes. At week 6, the RBAC group scored 75.8 ± 14.41 in mean QL2 compared to 57.6 ± 17.93 in the placebo group ( p = 0.017, Cohen’s d = 1.118). The mean QL2 difference between RBAC and placebo at week 24 was 79.2 ± 19.74 and 57.41 ± 24.81, respectively ( p = 0.041, Cohen’s d = 0.971). Figure 2 shows the difference in mean QL2 scores between groups over time. The plot shows a dip in the global QoL of the placebo group at week 6, which recovered over the subsequent two visits before dropping again at the last visit (week 24). Conversely, the RBAC group showed an upward trend at week 6 and minor drops at weeks 12 and 18 before improvement at week 24. However, these differences over time were not statistically significant in pairwise comparison. Datasets of the remaining 14 scales/items for QLQ-C30 did not fulfil the normality criterion of RM ANOVA and were analysed based on nonparametric tests with ANOVA-type statistics. The results are shown in Table 3. Among the five functional scales of QLQ-C30, statistical differences between groups were detected in role (RF2, p < 0.001) and social functioning (SF, p = 0.037). Meanwhile, the difference in cognitive functioning was marginally significant (CF, p = 0.054). There was also a marginally significant difference between groups concerning financial difficulties (FI, p = 0.058). The RTE of both groups were compared at each visit for these functional scales, as visualised in Figure 3. The RBAC group demonstrated superior results compared to the placebo group on these functional scales, indicating a higher or healthier level of functioning in these domains. Most notably, participants taking RBAC reported significantly better role functioning ( p < 0.05) than their placebo counterparts at every visit after baseline, most prominently at weeks 12 and 18 ( p < 0.01). The RBAC group also reported significantly higher social functioning than the placebo group at weeks 6 and 12. Pairwise comparisons in cognitive functioning found no significant differences between the groups over time. Worsening outcomes in functioning may have contributed to greater concerns over financial difficulties in the placebo group, as shown in Figure 3. In terms of symptom scores, significant between-group differences ( p < 0.05) were detected for fatigue, pain, dyspnoea, and appetite loss. As shown in Figure 3, the placebo group exhibited higher RTE values than the RBAC group in each of these symptom measures, indicating a greater level of symptomatology or problems in these areas. Pairwise comparisons found significant differences between the groups at weeks 18 and 24 for dyspnoea ( p < 0.05) and at week 12 for appetite loss ( p < 0.01). Secondary outcome analysis RM ANOVA was conducted on body weight, BMI, plus nutritional status indices of NLR and INI (See Supplementary S1). No statistically significant differences were detected between the groups at baseline and across all time points for these parameters. Therefore, this study was not able to explain the effect of RBAC on QoL beyond that of placebo based on the outcome measures. Cytokine profile analysis Cytokine profile analysis was an optional exploratory outcome measure for study sites due to additional logistics requirements for collecting, centrifuging, transporting and storing serum samples. Consequently, the cytokine profile analysis was performed with samples from only 19 participants (RBAC = 9, placebo = 10). Fourteen participants (7 in each group) fully completed the trial. Notwithstanding. among the 15 cytokines/chemokines analysed with RM ANOVA, three parameters yielded significant differences across time: IFN-γ (F[4, 44] = 2.887, p = 0.033, eta 2 [g] = 0.017), IL-1RA (F[4, 44] = 2.716, p = 0.042, eta 2 [g] = 0.030), and IL-12p40 (F[4, 44] = 2.716, p = 0.038, eta 2 [g] = 0.027). However, the effect sizes (eta 2 [g]) of the differences are considered small. Table 4 shows the pairwise comparisons of the means of IFN-γ, IL-1RA, and IL-12p40 for the two groups across different time points. Due to the small effect sizes, no significant differences were detected for all measures at individual time points. Nonetheless, for IFN-γ, at week 18, the difference between RBAC and placebo groups was marginally significant (1.91 ± 0.20 vs. 1.69 ± 0.23, p = 0.065). Overall, the RBAC group demonstrated slightly higher cytokine activities than the placebo group (Figure 4). Safety outcome analysis The study did not detect any safety issues in any of the participants based on routine clinical assessments, including complete blood count, liver function, electrolytes, urea, creatinine and prealbumin. Based on RM ANOVA analysis, three markers, namely white blood cell count (WBC), total protein (TP) and aspartate transferase (AST), showed significant differences. The WBC (F[4, 60] = 2.540, p = 0.049, eta 2 [g] = 0.071) and AST (F[4, 60] = 2.855, p = 0.031, eta 2 [g] = 0.040) were significantly different across time, whereas TP showed a significant interaction effect between group and time (F[4, 56] = 3.057, p = 0.024, eta 2 [g] = 0.051). Table 5 shows the pairwise comparisons of the means of WBC, TP, and AST for the two groups across different time points. A significant difference in TP was observed at week 18, with the RBAC group showing 74.88 ± 6.81 g/L compared to 67.78 ± 5.36 g/L) in the placebo group ( p = 0.030, Cohen’s d = 1.158). Trends in the WBC, TP, and AST for the two groups over time are visualised in Figure 5. Although time effects were detected as statistically significant with RM ANOVA, pairwise comparisons of different time points by groups did not yield any significant difference after the p -values were corrected for multiplicity using FDR. Correlations of significant outcomes Table 6 shows the pairwise correlation coefficients of the QL2, IFN-γ, IL-1RA, IL-12p40, WBC, AST, and TP as significant outcomes of this trial. A linear association between the global QoL of the participants (QL2) with IL-1RA ( r = 0.245), IL-12p40 ( r = 0.246) and TP ( r = 0.310) was detected, demonstrating a positive link between QoL and the immune response (IFN-γ, IL-1RA, IL-12p40) and nutritional status (TP). IL-1RA and IL-12p40 exhibited a very high correlation ( r = 0.907), indicating the interrelatedness of these two cytokines. Although the correlation between IFN-γ and QL2 was not significant ( r = 0.168), the level of antitumour IFN-γ did exhibit strong correlations with both IL-1RA ( r = 0.738) and IL-12p40 ( r = 0.804). Moreover, the WBC level was also shown to correlate positively with TP ( r = 0.407) and with the cytokines of IFN-γ ( r = 0.211), IL-1RA ( r = 0.205) and IL-12p40 ( r = 0.200). These results suggest that cellular immunity plays a vital role in the observed improved QoL of the RBAC group over the placebo group. In contrast, the liver function test, AST, correlates negatively with IFN-γ ( r = 0.240), IL1-RA ( r = 0.270) and TP ( r = 0.258). Analysis of lifestyle factors RM ANOVA was applied to analyse the Australian Recommended Food Score (ARFS) derived from AES for diet assessment (19), metabolic equivalent of task (MET) score for physical activity and CAMQ score for usage and belief in complementary therapies. Analyses of ARFS and CAMQ scores were unremarkable (See Supplementary S1). Only the MET score showed a significant difference for time effect (F[4, 56] = 4.193, p = 0.005, eta 2 [g] = 0.134). However, pairwise comparisons between time points by group did not reveal any significant difference for both groups after adjustment for multiple comparisons. The differences in mean MET scores between time points also did not reach statistical significance after combining the data from all participants. Changes in physical activity levels over time are illustrated in Figure 6. The participants had low to moderate levels of physical activity at the start of treatment (weeks 0 to 6) but became more active at weeks 12 and 18 (moderate to high) while slowing down at the end of their treatment (week 24). Both groups reported similar physical activity behaviours with no significant difference in MET score at any time point. Hence, physical activity level was not likely a confounding variable that could influence the between-group differences in the current research. Adjusted analysis Adjusted analysis with ANCOVA was not performed as there were no significant differences between groups in the participants’ baseline characteristics and lifestyle factors. Adverse events Comparisons between the two groups regarding the adverse events reported during the trial period are shown in Table . The mean adverse events reported per participant in the RBAC group was lower at 2.33 ±3.22 compared to 4.59 ±2.87 in the placebo group, although the difference did not reach statistical significance ( p = 0.066). Adverse events based on the CTCAE classification were mostly mild (RBCA = 75.0%, placebo = 79.5%) and moderate (RBCA = 21.4%, placebo = 11.5%), with the grading distribution not significantly different between groups. Notwithstanding, there was one incident of life-threatening bowel obstruction in the placebo group where the patient was hospitalised. The event was resolved and deemed unlikely to be related to the study intervention. In the RBAC group, one death resulted from complications from a fast-growing malignancy unrelated to the study intervention two weeks after starting the trial. There was also a death incident in the placebo group; the participant missed visit 3 and subsequently withdrew from the trial due to a deteriorating condition and passed away one week later. Overall, there was a significant difference in the distribution of the most commonly reported adverse events between groups ( p = 0.006). Fatigue was the most common adverse event reported in both groups (RBAC = 14.3%, placebo = 12.8%), followed by diarrhoea and nausea. Oral thrush and rash were reported in the placebo group, but not in the RBAC group. Other commonly reported adverse events include constipation, cough, peripheral neuropathy, pain, and shortness of breath. These adverse events were typical side-effects of oncological treatment and thus considered not related (RBAC = 53.6%, placebo = 70.5%) or unlikely to be related (RBAC = 42.9%, placebo = 26.9%) to the study interventions. Nonetheless, the oncologists rated three adverse events (diarrhoea, abdominal pain, and dysgeusia) as possibly study-related at the time of reporting, with one in the RBAC group and two in the placebo group. As these adverse events were mild and mostly resolved during the trial, they were subsequently deemed not likely to be caused by the study interventions. Overall, RBAC was considered as safe to consume. Discussion This pilot study determined that RBAC improved patients’ overall QoL during active cancer treatment, with a statistically significant difference compared to placebo. Notably, the mean global QoL scales of participants taking RBAC were significantly higher than those taking placebo at weeks 6 and 24, with effect size estimates (Cohen’s d ) of 1.118 and 0.971, respectively. Based on the evidence-based guidelines by Cocks, King (21) for the interpretation of QLQ-C30, the effect size of cross-sectional differences in the global QoL for clinical relevance can be interpreted as small (0.2–0.4), medium (0.4–0.6), or large (> 0.6). Hence, the QoL differences observed in this study were considered large and thus clinically significant. Such favourable results in QoL maintenance with RBAC are consistent with the findings of Tan and Flores (25), who reported a statistically significant difference in the mean global QoL scales ( p = 0.019), favouring RBAC over placebo two months after radiation treatment in participants with head and neck cancers. The final results of global QoL scores are also consistent with those observed during the interim analysis (15), albeit with a marginally lower effect size estimate (0.147 vs. 0.267). Since the effect size statistic measures the variance of the sample rather than the population, it will tend to overestimate the effect size with a small sample and the bias is reduced with a larger cohort (26). Notably, a matched comparison of 33 interim-final analyses in oncology clinical trials reported that the effect sizes of final analyses were lower by a median of 31% compared to the effect sizes from interim analyses (27). Hence, a reduction in the effect size estimate in the present study is within expectation. In addition to improving global QoL, participants in the RBAC group reported significantly lower symptom severity for fatigue, pain, dyspnoea, and appetite loss compared to the placebo group, as measured by the EORTC QLQ-C30. RTE estimates indicated significantly greater reductions in these symptoms in the RBAC group compared to the placebo group at multiple time points, most notably for appetite loss at week 12 ( p < 0.01) and dyspnoea at week 18 ( p < 0.05). This finding is supported by a marginally lower mean number of adverse events per participant in the RBAC group compared to the placebo group (2.33 ± 3.22 vs. 4.59 ± 2.87). These findings suggest that the relatively reduced symptom burden during cancer treatment may have contributed to improved role, social, and possibly cognitive functioning in the RBAC group as well as lowering the perceived cancer-related financial stress. Consistent with these results, Masood, Sheikh (28) reported that breast cancer patients taking RBAC during six cycles of chemotherapy experienced fewer incidences of anorexia/tiredness, nausea/vomiting, alopecia, and weight loss compared to the control group who did not take RBAC. Similarly, Petrovics, Szigeti (29) demonstrated that in cancer patients with chronic fatigue syndrome, RBAC plus oncothermia, a specialised type of hyperthermia targeting tumours, significantly alleviated fatigue symptoms ( p < 0.001) compared to the control group, during active treatment. The higher occurrence of adverse events and side effects from the cancer treatment led to a higher dropout in the placebo group in this study. Specifically, seven out of the 16 who received the placebo (43.75%) discontinued the trial, compared to only one out of 11 participants in the RBAC group (9.09%). The higher dropout rate in the placebo group could be partially due to the higher number of participants receiving chemotherapy treatment in the placebo ( n = 12) versus RBAC ( n = 7), as chemotherapy is known to be less tolerable than immunotherapy in advanced solid-organ malignancies (30). Five of the seven participants in the placebo group who dropped out were undergoing chemotherapy (one with stage IV cancer and four with stage III cancer). This disparity in attrition rates, despite the blinded design, raises potential concerns about the study's internal validity; however, it does not necessarily bias the results (31). In clinical research, lower health-related QoL values are known to be related to dropout and death. Most prominently, the global QoL scale, role functioning, physical functioning, and fatigue symptom score in the QLQ-C30 were key early dropout indicators, according to Gebert, Schindel (32). Hence, unequal dropout rates should be expected if one group has a significantly better QoL in a controlled trial. Another randomised controlled trial of RBAC also observed a considerable disparity in dropout rates, albeit in a different cancer patient group. Takahara and Sano (33) evaluated the adjunctive effects of RBAC on standard complementary and supportive care in people with progressive and metastasised cancer over 18 months. Of the 109 assigned to the control group, 53 (49%) patients dropped out due to increased intensity of cancer-related symptoms and did not survive at the end of the trial. In contrast, no dropout was observed in the RBAC group ( n = 96). The QoL scores improved in both groups among those who remained in the trial, but the RBAC group had a better increase in appetite. Thus, future trials of RBAC supplements should consider incorporating dropout rates due to adverse events as a formal outcome measure as it could be an indirect indicator for QoL. Nutritional status strongly predicts QoL in cancer patients (34). However, no significant between-group differences in body composition parameters and nutritional status indices (INI and NLR) were detected in this study. The discordance could be due to the small sample size, the heterogeneity in cancer types, and the aptness of the chosen outcome measures. Notwithstanding, the present research revealed significant differences in TP between RBAC and the placebo group with a medium effect size. Specifically, the RBAC group showed a significantly higher TP level at week 18 compared to the placebo group, even though TP levels of both groups remained within the normal range. Furthermore, TP and global QoL scores showed a positive correlation. Chemotherapy is known to lower serum TP due to its toxicity (35). An improved TP level in the present study suggests that RBAC could better preserve the hepatic and renal function during treatment contributing to better QoL. Serum TP level, along with its components of albumin and globulin and their ratio (A/G ratio), has been suggested as markers for protein-energy malnutrition by Rahman and Begum (36). However, this study found no significant between-group differences in albumin level and A/G ratio over time. Thus, the impact of RBAC on the nutritional status of cancer patients during treatment remains unclear and needs further investigation. In the previous interim analysis of the same trial (15), there was also a significant difference in WBC between group and time. Additionally, the TP level was strongly correlated with WBC. This final analysis, however, yields a much weaker correlation between TP and WBC, and thus does not support the proposition that RBAC could potentially improve QoL through preserving WBC level and nutritional status. Hence, further research is required to explore the underlying mechanisms that influence the QoL enhancement effect of RBAC in cancer patients. For example, the inflammatory-induced tryptophan-kynurenine pathway linked to fatigue, depression, and decreased QoL in patients with solid tumours can be a potential candidate for investigation in future studies (37). Two earlier studies reported that RBAC could modulate the cytokine profile of cancer patients. Cholujova, Jakubikova (38) reported that the plasma concentrations of both the Th1 (IL-12, IL-17, TNF-α, and INF-γ) and Th2 (IL-4, IL-6, IL-9, IL-10, and IL-13) cytokines in multiple myeloma patients were significantly elevated ( p < 0.05) by RBAC ( n = 32) compared to placebo ( n = 16) after three months in a randomised controlled trial. In another non-randomised trial, Kim, Hong (39) also reported that cancer patients ( n = 10) who consumed an oral nutritional supplement containing 0.4 g of rice bran bio-exopolymer, a variation of RBAC, had significantly lower levels of IL-1β, IL-6, and IL-8 and a higher level of IL-12p70 ( p < 0.05) compared to a control group ( n = 24) receiving nutritional counselling only. The current study also found evidence of cytokine modulation by RBAC with significant differences in IFN-γ, IL-1RA, and IL-12p40 over time between RBAC and placebo groups. The RBAC group appeared to have elevated levels of these cytokines compared to the placebo group. Moreover, these cytokines showed positive correlations with global QoL and WBC. IFN-γ is a pleiotropic cytokine produced mainly by NK cells and NK T cells, which exhibited antitumour, antiviral, and immunomodulatory functions (40). An animal study by Badr El-din, Noaman (41) showed that tumour-bearing mice treated with RBAC had significantly higher IFN-γ levels (154.54%) that contributed to significantly lower tumour volume (63.27%) and tumour weight (45.2%) as compared to controls ( p < 0.01). IL-1RA is an anti-inflammatory cytokine that counteracts tumour growth and promotes malignant cell apoptosis through the IL-1 signalling pathway. As such, IL-1RA therapy has been used as an anticancer adjuvant to augment the therapeutic efficacies of chemotherapy and immunotherapy (42). IL-12p40 is a subunit of the IL-12 cytokine produced by dendritic cells to activate the Th1 response and stimulate NK cells to secret IFN-γ (43). In colorectal cancer patients, circulating IL-12p40 levels decreased significantly with disease progression (44). Hence, the elevated levels of IFN-γ, IL-1RA, and IL-12p40 in the RBAC group could result from the immunomodulatory effects of RBAC, particularly through inducing dendritic cell maturation, upregulating NK cell activity, promoting tumour cell apoptosis as previously described in the literature (11, 45). It should be noted that the effect size estimates of IFN-γ, IL-1RA, and IL-12p40 were small, and no significant differences were detected in post-hoc analysis with pairwise comparisons. The cytokine profile analysis was an optional trial component performed on a subset of participants (19 out of 29). Due to the limited sample size and small effects, this pilot trial has insufficient power to detect the between-group differences in cytokine profiles at each time point. Therefore, the impact of RBAC intervention on cytokine profiles during active cancer treatment observed in this study is suggestive and should be validated in future research. This pilot study aimed to inform the design of a large-scale clinical trial. Based on the effect size (eta2[g]) of 0.147 for the global QoL scale, a sufficiently powered study needs a sample size of 88 to achieve the estimated power of 95% based on the a priori power analysis of RM ANOVA (2 groups and 5 measurements, α = 0.5, 1-β = 0.95) for within-between interactions. However, anticipating an unequal dropout rate between groups, the future trial should target to recruit up to 115 participants, randomly allocating 66 (~ 40% extra) in the placebo group and 49 (~ 10% extra) in the RBAC group based on an allocation ratio of approximately 1.35 (placebo) to 1 (RBAC). This study has several limitations. The most notable is the small sample size, which necessitates validation of the results with a larger study. The short trial duration (6 months) also offers no opportunity to observe the participants’ QoL posttreatment. Thus, it is unclear how long the QoL-improving effects of RBAC could last. Additionally, the lack of posttreatment follow-up also renders no outcome data for validating whether RBAC treatment could improve the survival odds of cancer patients. Nonetheless, the positive findings provide valuable insights into the therapeutic potential of RBAC in cancer treatment and lay the foundation for further translational research of RBAC. Conclusions The RBAC-QoL study showed favourable results, indicating that RBAC improves the QoL for cancer patients undergoing active treatment. Compared to the placebo group, participants in the RBAC group reported better global QoL scores and significantly lower rates of fatigue, pain, dyspnoea, and appetite loss. RBAC was safe to consume with no known adverse effects. The observed reduction in symptoms experienced during cancer treatment also led to better role and social functioning. Additionally, significant increases in serum TP, IFN-γ, IL-1RA, and IL-12p40 were observed in the RBAC group over time, and the TP, IL-1RA, and IL-12p40 showed positive correlations with the global QoL scales. These findings suggest potential interactions between nutritional status, immune modulation, and QoL. However, with a small sample size, the findings should be interpreted cautiously and cannot be relied on as evidence of treatment efficacies. Regardless, this analysis provides valuable information and justification for a larger clinical trial to confirm RBAC’s beneficial effects on cancer patients’ QoL. Abbreviations The following abbreviations are used in this manuscript: AES Australian Eating Survey ANOVA Analysis of variance ANCOVA Covariance analysis ARFS Australian Recommended Food Score BMI Body mass index CAMQ Use of Complementary and Alternative Medicine Questionnaire CONSORT Consolidated Standards of Reporting Trials Cr Creatinine CTCAE Common Terminology Criteria for Adverse Events EORTC European Organisation for the Research and Treatment of Cancer HREC Human Research Ethics Committee IFN Interferon IL Interleukin INI Inflammatory-nutritional index IPAQ International Physical Activity Questionnaire mATS modified ANOVA-type statistic MET Metabolic equivalent of task NK Natural killer NLR Neutrophil-to-lymphocyte ratio QL2 Global QoL scale QLQ-C30 Core 30-item QoL questionnaire QoL Quality of life RBAC Rice bran arabinoxylan compound RM Repeated measures RNA Ribonucleic acid RTE Relative treatment effects TNF Tumour necrosis factor-alpha TP Total protein WBC White blood cell count Declarations Ethics approval and consent to participate This study was approved by the Human Research Ethics Committee (HREC) of Concord Repatriation General Hospital, Sydney Local Health District (Application No. 2019/ ETH00489) and Charles Sturt University HREC (Protocol No. H19244) All participants in the study provided written informed consent before starting the trial. Consent for publication The manuscript has been read and approved by all named authors, and there are no other persons who satisfied the criteria for authorship but are not listed. All authors had agreed to the publication. The manuscript contains no participant’s personal data in any form. Availability of data and materials The datasets generated and/or analysed during the current study are not publicly available due to commercial funding agreement but are available from the corresponding author for non-commercial research use on reasonable request. Competing interests All authors have no conflicts of interest to declare. Funding This clinical trial is funded by Daiwa Pharmaceutical Co., Ltd. (Japan) and BioMedica Nutraceuticals Pty Ltd. (Australia). The funding bodies were not involved in study design, data collection, management, analysis, interpretation, or the decision to submit for publication. Author contributions SLO : Conceptualisation, Methodology, Software, Formal analysis, Investigation, Data Curation, Writing - Original Draft, Visualisation. PSM: Conceptualisation, Methodology, Validation, Writing - Review & Editing. RZ : Conceptualisation, Methodology, Investigation, Validation, Resources, Writing - Review & Editing. SCP : Conceptualisation, Methodology, Validation, Resources, Writing - Review & Editing, Supervision, Project administration. JL : Resources, Writing - Review & Editing. SK : Investigation, Resources, Writing - Review & Editing. SG , TG : Writing - Review & Editing. Acknowledgement The authors acknowledge the assistance of Emily Schupfer, Tegan Grosfeld, and Ki Kwon in trial coordination and data collection for this study. SLO acknowledges support through the Australian Government Research Training Program scholarship for his PhD study. This study contributed toward the Ph.D. degree for SLO. References Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer; 2024 [Available from: https://gco.iarc.who.int/today. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2024;74(3):229 − 63. Tamburini M, Casali PG, Miccinesi G. Outcome assessment in cancer management. Surgical Clinics of North America. 2000;80(2):471 − 86. Palumbo MO, Kavan P, Miller W, Panasci L, Assouline S, Johnson N, et al. Systemic cancer therapy: achievements and challenges that lie ahead. Frontiers in Pharmacology. 2013;4:57. Katta B, Vijayakumar C, Dutta S, Dubashi B, Nelamangala Ramakrishnaiah VP. The incidence and severity of patient-reported side effects of chemotherapy in routine clinical care: A prospective observational study. Cureus. 2023;15(4):e38301. Firkins J, Hansen L, Driessnack M, Dieckmann N. Quality of life in “chronic” cancer survivors: a meta-analysis. Journal of Cancer Survivorship. 2020;14(4):504 − 17. Jitender S, Mahajan R, Rathore V, Choudhary R. Quality of life of cancer patients. Journal of Experimental Therapeutics and Oncology. 2018;12(3):217 − 21. Nguyen LB, Vu LG, Le TT, Nguyen XT, Dao NG, Nguyen DC, et al. Impact of interventions on the quality of life of cancer patients: a systematic review and meta-analysis of longitudinal research. Health and Quality of Life Outcomes. 2023;21(1):112. Nolazco JI, Chang SL. The role of health-related quality of life in improving cancer outcomes. Journal of Clinical and Translational Research. 2023;9(2):110-4. Olver I, Keefe D, Herrstedt J, Warr D, Roila F, Ripamonti CI. Supportive care in cancer—a MASCC perspective. Supportive Care in Cancer. 2020;28(8):3467-75. Ooi SL, Micalos PS, Kim J, Pak SC. Rice bran arabinoxylan compound as a natural product for cancer treatment – an evidence-based assessment of the effects and mechanisms. Pharmaceutical Biology. 2024;62(1):367 − 93. Ooi SL, McMullen D, Golombick T, Pak SC. Evidence-based review of BioBran/MGN-3 arabinoxylan compound as a complementary therapy for conventional cancer treatment. Integrative Cancer Therapies. 2018;17(2):165 − 78. Ooi SL, Pak SC, Micalos PS. Health-related quality of life. In: Pak SC, Ooi SL, Micalos PS, Ghoneum MH, editors. Modified rice bran arabinoxylan: Therapeutic applications in cancer and other diseases. Singapore: Springer Nature; 2023. p. 87–99. Ooi SL, Pak SC, Micalos PS, Schupfer E, Zielinski R, Jeffries T, et al. Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial. Contemporary Clinical Trials Communications. 2020;19:100580. Ooi SL, Micalos PS, Zielinski R, Pak SC. Rice bran arabinoxylan compound and quality of life (RBAC-QoL) of cancer patients: An interim analysis of the RBAC-QoL Study. Cureus. 2024;16(1):e53188. The National Clinical Trials Governance Framework and User Guide for Health Service Organisations Conducting Clinical Trials. Sydney, Australia: Australia Government Department of Health; 2022. Schulz KF, Altman DG, Moher D, the CG. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Medicine. 2010;8(1):18. Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, et al. EORTC QLQ-C30 scoring manual. Brussels, Belgium: European Organisation for Research and Treatment of Cancer,; 2001. Collins CE, Burrows TL, Rollo ME, Boggess MM, Watson JF, Guest M, et al. The comparative validity and reproducibility of a diet quality index for adults: The Australian Recommended Food Score. Nutrients. 2015;7(2):785 − 98. Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the international physical activity questionnaire short form (IPAQ-SF): A systematic review. International Journal of Behavioral Nutrition and Physical Activity. 2011;8(1):115. Cocks K, King MT, Velikova G, Martyn St-James M, Fayers PM, Brown JM. Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Journal of Clinical Oncology. 2011;29(1):89–96. Noguchi K, Gel YR, Brunner E, Konietschke F. nparLD: An R software package for the nonparametric analysis of longitudinal data in factorial experiments. Journal of Statistical Software. 2012;50(12):1–23. Brunner E, Puri ML. Nonparametric methods in factorial designs. Statistical Papers. 2001;42(1):1–52. Falci SG, Marques LS. CONSORT: when and how to use it. Dental Press Journal of Orthodontics. 2015;20(3):13 − 5. Tan DFS, Flores JAS. The immunomodulating effects of arabinoxylan rice bran ( Lentin ) on hematologic profile, nutritional status and quality of life among head and neck carcinoma patients undergoing radiation therapy: A double blind randomized control trial. Radiology Journal, The Official Publication of the Philippine College of Radiology [Internet]. 2020; 12(February):[11 − 6 pp.]. Available from: https://philippinecollegeofradiology.org.ph/wppcr/wp-content/uploads/Radiology-Journal-2020.pdf. Olejnik S, Algina J. Generalized eta and omega squared statistics: measures of effect size for some common research designs. Psychological Methods. 2003;8(4):434 − 47. Wayant C, Vassar M. A comparison of matched interim analysis publications and final analysis publications in oncology clinical trials. Annals of Oncology. 2018;29(12):2384-90. Masood AI, Sheikh R, Anwer RA. “BIOBRAN MGN-3"; effect of reducing side effects of chemotherapy in breast cancer patients. The Professional Medical Journal [Internet]. 2013; 20(1):[13 − 6 pp.]. Available from: http://www.theprofesional.com/index.php/tpmj/article/view/4869. Petrovics G, Szigeti G, Hamvas S, Mate A, Betlehem J, Hegyi G. Controlled pilot study for cancer patients suffering from chronic fatigue syndrome due to chemotherapy treated with BioBran (MGN-3 Arabinoxylane) and targeted radiofrequency heat therapy. European Journal of Integrative Medicine. 2016;8:29–35. Magee DE, Hird AE, Klaassen Z, Sridhar SS, Nam RK, Wallis CJD, et al. Adverse event profile for immunotherapy agents compared with chemotherapy in solid organ tumors: a systematic review and meta-analysis of randomized clinical trials. Annals of Oncology. 2020;31(1):50–60. Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013;346:e8668. Gebert P, Schindel D, Frick J, Schenk L, Grittner U. Characteristics and patient-reported outcomes associated with dropout in severely affected oncological patients: an exploratory study. BMC Medical Research Methodology. 2021;21(1):77. Takahara K, Sano K. The life prolongation and QOL improvement effect of rice bran arabinoxylan derivative (MGN-3, Biobran) for progressive cancer. Clinical Pharmacology and Therapy. 2004;14(3):267–71. Lis CG, Gupta D, Lammersfeld CA, Markman M, Vashi PG. Role of nutritional status in predicting quality of life outcomes in cancer – a systematic review of the epidemiological literature. Nutrition Journal. 2012;11(1):27. Abbasi B, Hayat A, Lyons M, Gupta A, Gupta S. Serum protein and electrolyte imbalances are associated with chemotherapy induced neutropenia. Heliyon. 2022;8(7). Rahman MZ, Begum BA. Serum total protein, albumin and A/G ratio in different grades of protein energy malnutrition. Mymensingh Medical Journal. 2005;14(1):38–40. Lanser L, Kink P, Egger EM, Willenbacher W, Fuchs D, Weiss G, et al. Inflammation-induced tryptophan breakdown is related with anemia, fatigue, and depression in cancer. Frontiers in Immunology. 2020;11:249. Cholujova D, Jakubikova J, Czako B, Martisova M, Hunakova L, Duraj J, et al. MGN-3 arabinoxylan rice bran modulates innate immunity in multiple myeloma patients. Cancer Immunol Immunother. 2013;62(3):437–45. Kim JM, Hong SG, Song BS, Sohn HJ, Baik H, Sung MK. Efficacy of cereal-based oral nutrition supplement on nutritional status, inflammatory cytokine secretion and quality of life in cancer patients under cancer therapy. Journal of Cancer Prevention. 2020;25(1):55–63. Jorgovanovic D, Song M, Wang L, Zhang Y. Roles of IFN-γ in tumor progression and regression: A review. Biomarker Research. 2020;8(1):49. Badr El-din NK, Noaman E, Ghoneum M. In vivo tumor inhibitory effects of nutritional rice bran supplement MGN-3/Biobran on Ehrlich carcinoma-bearing mice. Nutrition and Cancer. 2008;60(2):235–44. Fang Z, Jiang J, Zheng X. Interleukin-1 receptor antagonist: An alternative therapy for cancer treatment. Life Sciences. 2023;335:122276. Shemesh A, Pickering H, Roybal KT, Lanier LL. Differential IL-12 signaling induces human natural killer cell activating receptor-mediated ligand-specific expansion. Journal of Experimental Medicine. 2022;219(8):e20212434. Stanilov N, Miteva L, Jovchev J, Cirovski G, Stanilova S. The prognostic value of preoperative serum levels of IL-12p40 and IL-23 for survival of patients with colorectal cancer. APMIS. 2014;122(12):1223-9. Ooi SL, Pak SC, Micalos PS, Schupfer E, Lockley C, Park MH, et al. The health-promoting properties and clinical applications of rice bran arabinoxylan modified with shiitake mushroom enzyme – a narrative review. Molecules. 2021;26(9):2539. Tables Table 1. Participant characteristics RBAC Placebo p -value N (available for analysis) 12 (100%) 17 (100%) Age 68.8 ±9.17 64.1 ±7.35 p = 0.152 Sex Male 7 (58.3%) 14 (83.3%) p = 0.218 Female 5 (41.7%) 3 (17.7%) Body Composition Weight 79.0 ±24.38 86.2 ±18.26 p = 0.381 Body Mass Index 27.6 ±7.79 27.6 ±4.67 p = 0.988 Primary Cancer Lung 2 (16.7%) 6 (35.3%) p = 0.268 Melanoma 4 (33.4%) 2 (11.7%) Colon and Rectum 1 (8.3%) 4 (23.5%) Ovary and Uterus 3 (25.0%) 1 (5.9%) Bladder 1 (8.3%) - Stomach 1 (8.3%) - Breast - 1 (5.9%) Oesophagus - 1 (5.9%) Pleura - 1 (5.9%) Kidney - 1 (5.9%) Cancer Stage II 1 (8.4%) 1 (5.9%) p = 0.847 III 4 (33.3%) 8 (47.1%) IV 7 (58.3%) 8 (47.1%) Recurrence No 7 (58.3%) 11 (64.7%) p = 1.0 Yes 5 (41.7%) 6 (32.3%) Metastasis No 2 (16.7%) 4 (23.5%) p = 1.0 Yes 10 (83.3%) 13 (76.5%) Treatment Chemotherapy 7 (58.3%) 12 (70.6%) p = 0.694 Immunotherapy 5 (41.7%) 5 (29.4%) Lifestyle Factors Diet (ARFS) 30.7 ±8.51 33.5 ±8.74 p = 0.456 Physical Activity (MET/week) 830.3 ±601.7 706.5 ±639.9 p = 0.399 CAMQ Score 15.8 ±12.74 11.1 ±12.41 p = 0.493 Trial Status Withdrawn 1 (8.3%) 7 (41.2%) p = 0.105 Deceased 1 (8.3%) 1 (5.9%) Completed 10 (83.4%) 9 (52.9%) All continuous variables are presented as mean ± standard deviation, and the hypothesis testing of two means was based on the two-sided Student’s t-test. Significant testing of categorical variables was determined using Fisher’s exact test. ARFS = Australian recommended food score; CAMQ= Use of complementary and alternative medicine questionnaire; MET = metabolic equivalent of task; RBAC = rice bran arabinoxylan compound. Table 3. Pairwise comparisons of mean global quality of life score (QL2) between groups over time. Visit Variable (unit) RBAC Placebo p -value Cohen’s d 0 (Baseline) QL2 (1-100) 70.8 ± 21.6 60.0 ± 19.0 0.156 0.533 1 (Week 6) QL2 (1-100) 75.8 ± 14.4 57.6 ± 17.9 0.017 * 1.118 2 (Week 12) QL2 (1-100) 73.1 ± 14.9 66.7 ± 13.4 0.315 0.457 3 (Week 18) QL2 (1-100) 70.4 ± 12.6 63.89 ± 19.5 0.486 0.394 4 (Week 24) QL2 (1-100) 79.2 ± 19.7 57.41 ± 24.8 0.041 * 0.971 ^ Statistically significant difference between two means based on the two-sided Student’s t-test with p ≤ 0.05 (with multiplicity adjusted with false discovery rate). RBAC = rice bran arabinoxylan compound. Table 3. The modified ANOVA-type statistic based on the group effect for 14 QLQ-C30 scales/items Scale/Item mATS Df1 Df2 p -value Physical Functioning (PF2) 2.36 1 18.35 0.141 Role Functioning (RF2) 22.21 1 19.85 < 0.001 * Emotional Functioning (EF) 0.09 1 18.82 0.767 Cognitive Functioning (CF) 4.17 1 19.49 0.054 + Social Functioning (SF) 4.99 1 19.41 0.037 * Fatigue (FA) 4.59 1 19.17 0.045 * Nausea & Vomiting (NV) < 0.01 1 18.16 0.967 Pain (PA) 4.43 1 19.42 0.048 * Dyspnoea (DY) 4.53 1 18.49 0.047 * Insomnia (SL) 0.45 1 19.96 0.508 Appetite Loss (AP) 4.64 1 20.00 0.044 * Constipation (CO) 0.06 1 19.35 0.804 Diarrhoea (DI) 0.80 1 13.91 0.387 Financial Difficulties (FI) 4.25 1 13.71 0.058 + * The statistically significant difference between groups (RBAC vs. Placebo) was based on the modified ANOVA-type statistic for the whole-plot factors (mATS) with p ≤ 0.05. + Marginal significance p ≈ 0.05. Df = Degree of freedom; RBAC = rice bran arabinoxylan compound. Table 4. Pairwise comparisons of interferon-gamma (IFN-γ), interleukin-1RA (IL-1RA), and interleukin-12p40 (IL-12p40) between groups over time. Visit Variable (unit) RBAC Placebo p -value Cohen’s d 0 (Baseline) IFN-γ (pg/ml) 1.86 ± 0.21 1.70 ± 0.26 0.164 0.673 1 (Week 6) IFN-γ (pg/ml) 1.84 ± 0.22 1.76 ± 0.19 0.468 0.400 2 (Week 12) IFN-γ (pg/ml) 1.91 ± 0.20 1.69 ± 0.23 0.065 1.019 3 (Week 18) IFN-γ (pg/ml) 1.86 ± 0.30 1.66 ± 0.21 0.147 0.786 4 (Week 24) IFN-γ (pg/ml) 1.92 ± 0.28 1.74 ± 0.20 0.186 0.714 0 (Baseline) IL-1RA (pg/ml) 1.70 ± 0.06 1.69 ± 0.08 0.703 0.179 1 (Week 6) IL-1RA (pg/ml) 1.73 ± 0.05 1.68 ± 0.07 0.195 0.762 2 (Week 12) IL-1RA (pg/ml) 1.72 ± 0.06 1.67 ± 0.08 0.166 0.752 3 (Week 18) IL-1RA (pg/ml) 1.71 ± 0.07 1.67 ± 0.08 0.360 0.493 4 (Week 24) IL-1RA (pg/ml) 1.74 ± 0.05 1.70 ± 0.05 0.157 0.780 0 (Baseline) IL-12p40 (pg/ml) 1.34 ± 0.06 1.34 ± 0.07 0.887 0.067 1 (Week 6) IL-12p40 (pg/ml) 1.35 ± 0.06 1.31 ± 0.07 0.297 0.592 2 (Week 12) IL-12p40 (pg/ml) 1.37 ± 0.06 1.31 ± 0.09 0.168 0.750 3 (Week 18) IL-12p40 (pg/ml) 1.37 ± 0.06 1.33 ± 0.08 0.308 0.556 4 (Week 24) IL-12p40 (pg/ml) 1.37 ± 0.05 1.34 ± 0.08 0.523 0.345 * The statistically significant difference between the two means is based on the two-sided Student’s t-test with p ≤ 0.05 (multiplicity adjusted with false discovery rate). RBAC = rice bran arabinoxylan compound. Table 5. Pairwise comparisons of white blood cell count (WBC), total protein (TP), and transferase (AST) between groups over time. Visit Variable (unit) RBAC Placebo p -value Cohen’s d 0 (Baseline) WBC (x10 9 /L) 5.86 ± 2.25 6.01 ± 1.91 0.844 -0.074 1 (Week 6) WBC (x10 9 /L) 5.36 ± 1.74 5.88 ± 2.11 0.545 -0.266 2 (Week 12) WBC (x10 9 /L) 6.41 ± 1.85 5.48 ± 2.76 0.392 0.398 3 (Week 18) WBC (x10 9 /L) 6.93 ± 1.88 5.70 ± 1.15 0.109 0.788 4 (Week 24) WBC (x10 9 /L) 6.88 ± 2.43 6.41 ± 2.35 0.686 0.196 0 (Baseline) TP (g/L) 71.80 ± 4.59 70.42 ± 6.45 0.576 0.247 1 (Week 6) TP (g/L) 70.88 ± 4.45 70.33 ± 5.29 0.824 0.111 2 (Week 12) TP (g/L) 74.13 ± 6.03 69.22 ± 4.71 0.080 0.906 3 (Week 18) TP (g/L) 74.88 ± 6.81 67.78 ± 5.36 0.030 * 1.158 4 (Week 24) TP (g/L) 71.56 ± 6.33 68.88 ± 4.61 0.340 0.484 0 (Baseline) Cr (µmol/L) 24.67 ± 9.36 24.00 ± 3.87 0.793 0.093 1 (Week 6) Cr (µmol/L) 28.80 ± 7.73 30.50 ± 7.45 0.606 -0.224 2 (Week 12) Cr (µmol/L) 26.78 ± 6.91 28.00 ± 4.77 0.636 -0.206 3 (Week 18) Cr (µmol/L) 27.90 ± 8.25 29.33 ± 6.06 0.675 -0.198 4 (Week 24) Cr (µmol/L) 31.50 ± 5.96 31.00 ±9.37 0.946 0.034 * The statistically significant difference between the two means is based on the two-sided Student’s t-test with p ≤ 0.05 (multiplicity adjusted with false discovery rate). RBAC = rice bran arabinoxylan compound. Table 6. Pairwise comparisons of the correlation among global quality of life score (QL2), interferon-gamma (IFN-γ), interleukin-1RA (IL-1RA), interleukin-12p40 (IL-12p40), white blood cell count (WBC), creatinine (Cr) and total protein (TP). Pearson’s r QL2 IFN- γ IL-1RA IL-12p40 WBC AST TP QL2 1 IFN- γ 0.168 1 IL-1RA 0.245 * 0.738 *** 1 IL-12p40 0.246 * 0.804 **** 0.907 **** 1 WBC 0.087 0.211 * 0.205 * 0.200 * 1 AST -0.054 -0.240 * -0.111 -0.270 * 0.029 1 TP 0.310 ** 0.051 -0.008 0.102 0.407 *** -0.258 * 1 Pearson correlation coefficient ( r ): * weak, ** moderate, *** strong, **** very strong. Table 7. Comparisons of the adverse events reported between RBAC and placebo groups. RBAC Placebo p -value Number of Participants (N) 12 17 Number of AEs reported 28 (100%) 78 (100%) Mean AE per patient 2.33 ± 3.22 4.59 ± 2.87 p = 0.066 CTCAE Grade 1 – Mild 21 (75.0%) 62 (79.5%) p = 0.365 2 – Moderate 6 (21.4%) 9 (11.5%) 3 – Severe 0 (0%) 0 (0%) 4 – Life-threatening 0 (0%) 1 (1.3%) 5 – Death 1 (3.6%) 1 (1.3%) Trial 1 – Not related 15 (53.6%) 55 (70.5%) p = 0.191 Relationship 2 – Unlikely 12 (42.9%) 21 (26.9%) 3 – Possible 1 (3.6%) 2 (2.6%) 4 – Probable 0 (0%) 0 (0%) 5 – Definite 0 (0%) 0 (0%) Most Common Fatigue 4 (14.3%) 10 (12.8%) p = 0.006 ** Events Diarrhoea 2 (7.1%) 4 (5.1%) Nausea 2 (7.7%) 4 (5.1%) Oral thrush 0 (0%) 6 (7.7%) Rash 0 (0%) 6 (7.7%) Constipation 1 (3.6%) 4 (5.1%) Cough 2 (7.1%) 3 (3.9%) Peripheral neuropathy 1 (3.6%) 3 (3.9%) Pain 1 (3.6%) 2 (2.6%) Shortness of breath 1 (3.6%) 2 (2.6%) Other isolated events 14 (50.0%) 34 (43.6%) Note: Continuous variable is presented in mean ± standard deviation, and the hypothesis testing of two means is based on the two-sided Student’s t-test. Significant testing of categorical variables is computed with Fisher’s exact test. AEs = Adverse events; CTCAE = Common Terminology Criteria for Adverse Events; RBAC = rice bran arabinoxylan compound. Additional Declarations No competing interests reported. Supplementary Files S1RMANOVAResults.docx Supplementary materials S1. Summary of RM-ANOVA Results (F-statistics) Cite Share Download PDF Status: Published Journal Publication published 02 Mar, 2026 Read the published version in Scientific Reports → Version 1 posted Editorial decision: Revision requested 11 Jan, 2026 Reviews received at journal 11 Jan, 2026 Reviewers agreed at journal 19 Dec, 2025 Reviewers agreed at journal 07 Sep, 2025 Reviews received at journal 18 Aug, 2025 Reviewers agreed at journal 24 Jul, 2025 Reviewers agreed at journal 10 Mar, 2025 Reviewers invited by journal 07 Mar, 2025 Editor assigned by journal 07 Mar, 2025 Editor invited by journal 22 Jan, 2025 Submission checks completed at journal 22 Jan, 2025 First submitted to journal 15 Jan, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5837950","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":430773410,"identity":"28a0d92c-845a-4418-a371-eaa3cfb00ed8","order_by":0,"name":"Soo Liang Ooi","email":"","orcid":"","institution":"Charles Sturt University","correspondingAuthor":false,"prefix":"","firstName":"Soo","middleName":"Liang","lastName":"Ooi","suffix":""},{"id":430773412,"identity":"07562c5c-871c-4b85-80e7-c068fb7ff362","order_by":1,"name":"Peter S Micalos","email":"","orcid":"","institution":"Charles Sturt University","correspondingAuthor":false,"prefix":"","firstName":"Peter","middleName":"S","lastName":"Micalos","suffix":""},{"id":430773413,"identity":"81eae71f-536c-457b-a5b4-3cbba5b1f391","order_by":2,"name":"Robert Zielinski","email":"","orcid":"","institution":"Western Sydney University","correspondingAuthor":false,"prefix":"","firstName":"Robert","middleName":"","lastName":"Zielinski","suffix":""},{"id":430773416,"identity":"75045c76-3db7-42c2-acf8-40d825a56ac4","order_by":3,"name":"Judith Lacey","email":"","orcid":"","institution":"Chris O’Brien Lifehouse","correspondingAuthor":false,"prefix":"","firstName":"Judith","middleName":"","lastName":"Lacey","suffix":""},{"id":430773417,"identity":"46525329-7207-4d76-96e4-6f1eacd27518","order_by":4,"name":"Suzanne Grant","email":"","orcid":"","institution":"Chris O’Brien Lifehouse","correspondingAuthor":false,"prefix":"","firstName":"Suzanne","middleName":"","lastName":"Grant","suffix":""},{"id":430773418,"identity":"72f9b757-d4ba-4ee6-812d-85f53918a7d3","order_by":5,"name":"Steven Kao","email":"","orcid":"","institution":"Chris O’Brien Lifehouse","correspondingAuthor":false,"prefix":"","firstName":"Steven","middleName":"","lastName":"Kao","suffix":""},{"id":430773419,"identity":"c346e624-b812-41a5-a7b8-c59b8fc1597a","order_by":6,"name":"Terry Golombick","email":"","orcid":"","institution":"St George Hospital","correspondingAuthor":false,"prefix":"","firstName":"Terry","middleName":"","lastName":"Golombick","suffix":""},{"id":430773420,"identity":"975b58fa-a4f6-440a-ae71-fc90db12ae7c","order_by":7,"name":"Sok Cheon Pak","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAtklEQVRIiWNgGAWjYHACZoYPEIYB8VoYZ5CshZmHJC3ys5sfG9vU1CU2sDdvk2CoOUxYi8GdY8bJOccOJzbwHCuTYDhGjBaJBOPDuQ0HEhskcswkGNiI0CI/I/3zYcsGoMPk3wC1/CNCC8ONHONkxgZmoC08ZhKMbUT55UyxYc+xw8ZtPGnFFol96UQ4bHb7ZokfNXWy/eyHN9748M2aCIdJQGk2EJFAhAaEllEwCkbBKBgFOAEAzoc1k6yHHMgAAAAASUVORK5CYII=","orcid":"","institution":"Charles Sturt University","correspondingAuthor":true,"prefix":"","firstName":"Sok","middleName":"Cheon","lastName":"Pak","suffix":""}],"badges":[],"createdAt":"2025-01-16 02:23:09","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5837950/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5837950/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41598-026-41554-8","type":"published","date":"2026-03-02T15:57:51+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":79094872,"identity":"fda93964-9cea-4e44-8801-89e727134442","added_by":"auto","created_at":"2025-03-24 10:42:05","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1002844,"visible":true,"origin":"","legend":"\u003cp\u003eThe recruitment flow of the RBAC-QoL study in a CONSORT diagram.\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-5837950/v1/1c7f580d3e14b912563993d0.png"},{"id":79094871,"identity":"4caf1123-7d5f-4923-a23f-588b15329b7d","added_by":"auto","created_at":"2025-03-24 10:42:05","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":60688,"visible":true,"origin":"","legend":"\u003cp\u003ePlots showing the mean (± standard error) for global quality of life scores (QL2) for RBAC and placebo groups over time. * Significant difference p ≤ 0.05. RBAC = rice bran arabinoxylan compound.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-5837950/v1/d8878aea99a65aef330948ad.png"},{"id":79096253,"identity":"a2a3c7d0-5877-4221-a23f-6a750dbd90cf","added_by":"auto","created_at":"2025-03-24 11:06:05","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":187135,"visible":true,"origin":"","legend":"\u003cp\u003ePlots showing the relative treatment effects (RTE with 95% confidence interval) between RBAC and placebo groups in terms of role functioning (RF2), social functioning (SF), cognitive functioning (CF), financial difficulties (FI), fatigue (FA), pain (PA), dyspnoea (DY) and appetite loss (AP) over time. Significant difference * p ≤ 0.05, ** p ≤ 0.01 and marginally \u003csup\u003e+\u003c/sup\u003e p ≈ 0.05. RBAC = rice bran arabinoxylan compound.\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-5837950/v1/3a3c9032604730d368fcdff1.png"},{"id":79094877,"identity":"13826fbe-04e9-4462-b15c-c825e169f4ed","added_by":"auto","created_at":"2025-03-24 10:42:05","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":127741,"visible":true,"origin":"","legend":"\u003cp\u003ePlots of (I) mean interferon-gamma (IFN-γ), (II) interleukin-1RA (IL-1RA), and (III) interleukin-12p40 (IL-12p40) for RBAC and placebo groups over time. * Significant difference p ≤ 0.05. RBAC = rice bran arabinoxylan compound.\u003c/p\u003e","description":"","filename":"Figure4.png","url":"https://assets-eu.researchsquare.com/files/rs-5837950/v1/4e6be516589f78fc6ea4bd18.png"},{"id":79095955,"identity":"7272c353-5679-4cb3-be96-7c80eae684c2","added_by":"auto","created_at":"2025-03-24 10:58:05","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":231580,"visible":true,"origin":"","legend":"\u003cp\u003ePlots of (I) mean white blood cell count (WBC), (II) total protein, and (III) aspartate transferase (AST) for RBAC and placebo groups over time. * Significant difference p ≤ 0.05. RBAC = rice bran arabinoxylan compound.\u003c/p\u003e","description":"","filename":"Figure5.png","url":"https://assets-eu.researchsquare.com/files/rs-5837950/v1/07ad74b583cab4551d316f45.png"},{"id":79094884,"identity":"bde1bebe-4e22-44db-9206-b39df411e186","added_by":"auto","created_at":"2025-03-24 10:42:05","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":82984,"visible":true,"origin":"","legend":"\u003cp\u003eA plot showing the physical activity levels (MET/week) for RBAC and placebo groups and all participants combined over time. RBAC = rice bran arabinoxylan compound.\u003c/p\u003e","description":"","filename":"Figure6.png","url":"https://assets-eu.researchsquare.com/files/rs-5837950/v1/e2fe36efcfe3320858b2382f.png"},{"id":104251890,"identity":"1eb41ebf-0894-4d18-9bb8-6cca0764fb4b","added_by":"auto","created_at":"2026-03-09 16:15:49","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":3410907,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5837950/v1/cc945c30-3214-4e47-a6e3-0f0ecd6c9ee0.pdf"},{"id":79095219,"identity":"bc12f49a-1a8f-414f-aedb-c509c18e8dbb","added_by":"auto","created_at":"2025-03-24 10:50:05","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":51592,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary materials\u003c/p\u003e\n\u003cp\u003eS1. Summary of RM-ANOVA Results (F-statistics)\u003c/p\u003e","description":"","filename":"S1RMANOVAResults.docx","url":"https://assets-eu.researchsquare.com/files/rs-5837950/v1/fa1a437f788f6143a8844e0c.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effects of Rice Bran Arabinoxylan Compound on Quality of Life of Cancer Patients During Active Treatment: A Randomised Placebo-controlled Pilot Trial","fulltext":[{"header":"Background","content":"\u003cp\u003eCancer is a global health concern. According to the Global Cancer Observatory data released by the International Agency for Research on Cancer, there were close to 20\u0026nbsp;million new cancer cases worldwide in 2022 and the disease caused approximately 9.7\u0026nbsp;million deaths (1). At this rate, nearly one in five people in the world will develop cancer in their lifetime (2).\u003c/p\u003e \u003cp\u003eSurvival is the primary outcome of concern in cancer therapies (3). Cytotoxic agents, including newer targeted therapies and immunotherapies, surgery and radiotherapy, are routinely used to eradicate malignant cells (4). Their administration also significantly affects healthy tissues and causes unwanted and common side effects such as nausea, vomiting, diarrhoea, appetite loss, peripheral neuropathy, fatigue and many others (5). As a result, cancer treatment can be physically and emotionally challenging for the patients, affecting them socially and financially.\u003c/p\u003e \u003cp\u003eCancer and its treatment could have long-term impacts on patients. With improvements in therapeutics coupled with early detection, people are now living longer after cancer diagnosis (6). Hence, there is a growing focus on the importance of supportive care rather than merely on cancer cure. The quality of life (QoL) outcome of cancer patients becomes a crucial clinical consideration (3, 7, 8). Improving the QoL of patients through complementary and supportive treatments has been suggested to enhance overall well-being and disease outcomes (9, 10).\u003c/p\u003e \u003cp\u003eRice bran arabinoxylan compound (RBAC) is a plant-based immunomodulator that has exhibited anticancer properties in research and demonstrated immune restorative function in cancer patients clinically by upregulating natural killer (NK) cell activity and enhancing inflammatory and cytotoxic responses (11). Previous reviews by the lead author (11, 12) found evidence showing RBAC as a complementary therapy used with conventional cancer treatment, which enhanced the immune profile, especially in boosting the NK cell activity, reduced treatment side effects, improved treatment outcomes and survival rates. RBAC was hypothesised to impact the QoL of cancer patients by improving immune function and lowering systemic inflammation, leading to reducing treatment toxicity, symptom severity, and behavioural comorbidities while enhancing the nutritional status and physical functioning (13). However, there is a lack of well-designed clinical trials assessing the impact of RBAC supplementation on the QoL of cancer patients using validated QoL instruments (11, 12).\u003c/p\u003e \u003cp\u003eThe present pilot study was conducted to obtain preliminary data for informing the design of a future large-scale clinical trial. This study utilises an internationally validated questionnaire, the European Organisation for the Research and Treatment of Cancer (EORTC) core 30-item QoL questionnaire (QLQ-C30), to determine the potential effects of RBAC compared with placebo on the QoL of cancer patients undergoing active anticancer treatment of either chemotherapy or immunotherapy. Secondary objectives were to ascertain potential associations between RBAC intervention, nutritional, and immune markers as possible mechanisms influencing the QoL of the patients.\u003c/p\u003e"},{"header":"Methods","content":" \u003cp\u003eTrial design\u003c/p\u003e \u003cp\u003eThe RBAC-QoL study was a randomised, placebo-controlled trial consisting of two parallel groups with a 1:1 allocation ratio. Before recruitment, the trial was approved by the Human Research Ethics Committee (HREC) of Concord Repatriation General Hospital, Sydney Local Health District (Application No. 2019/ ETH00489) and the Charles Sturt University HREC (Protocol No. H19244). The trial was also registered with the Australian New Zealand Clinical Trials Registry (ANZCTR Reg No: ACTRN12619000562178p; First registration on 10/04/2019).\u003c/p\u003e \u003cp\u003eThe study protocol was available for open access (14). A report documenting the approved protocol variations, statistical methods, and interim analysis has also been published (15). Readers are encouraged to refer to the earlier publications for further details. All methods were carried out in accordance with the principles, regulations, governance and guidelines for conducting clinical trials based on the National Clinical Trial Governance Framework of Australia (16). This report adheres to the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines (17).\u003c/p\u003e \u003cp\u003eEligibility criteria\u003c/p\u003e \u003cp\u003eThe inclusion criteria were adult patients (\u0026ge;\u0026thinsp;18 years old) diagnosed with any solid organ cancer (\u0026ge;\u0026thinsp;stage II) and undergoing chemotherapy or immunotherapy treatment at participating outpatient cancer centres while maintaining adequate bone marrow, liver, and kidney functions. The exclusion criteria were those with existing mental health conditions that might impede the ability to provide consent or those not able to complete the QoL questionnaire with minimal assistance; female patients who were pregnant, lactating, or planned to get pregnant during the period of the study; and anyone with active or prior documented autoimmune or inflammatory disorders (except autoimmune vitiligo or alopecia, stable hypothyroidism on hormone replacement, and any chronic skin condition that did not require systemic therapy) within the last five years.\u003c/p\u003e \u003cp\u003eParticipants\u003c/p\u003e \u003cp\u003eParticipants were recruited from four outpatient cancer centres in New South Wales, Australia, through doctor referrals or on-site advertising. Interested patients were provided with trial information by study coordinators trained in Good Clinical Practice. These potential participants were given at least 24 hours for consideration and informed discussions with their doctors and family members. The study coordinator would follow up with the patients for clarification and obtain written consent from willing participants under the supervision of the principal investigator on site. Participants were screened for eligibility before enrolment.\u003c/p\u003e \u003cp\u003eInterventions\u003c/p\u003e \u003cp\u003eThe participant took either RBAC or a placebo powder (dissolved in water) as an oral supplement (3g/day) for 24 weeks. Daiwa Pharmaceutical Co., Ltd. (Japan) manufactured and supplied the intervention packs in plastic sachets identical in appearance, containing RBAC or placebo powder with similar colour, odour, and taste. Further details on the RBAC and placebo used in this study were documented in the study protocol (14). All participants continued their oncological treatment during the trial and were required to attend five study visits, spaced six weeks apart, to provide data and undergo blood tests (total duration: 24 weeks).\u003c/p\u003e \u003cp\u003eOutcomes\u003c/p\u003e \u003cp\u003eThe primary outcome measure was self-reported QoL based on the QLQ-C30. Participants completed QLQ-C30 either on paper or electronically. Approval for QLQ-C30 use for research was obtained prior to study initiation. The scoring of QLQ-C30 followed the procedures stipulated by EORTC (18) with a global QoL scale, five functional scales (physical, role, emotional, cognitive, and social), and nine symptom-related measures (fatigue, nausea \u0026amp; vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) plus a financial difficulties item. Each scale/item was an outcome variable for analysis to determine the most appropriate primary measures that best reflect any potential effect of RBAC compared to placebo on the QoL of cancer patients.\u003c/p\u003e \u003cp\u003eThe secondary outcome measures of this study included body composition parameters (body weight, body fat ratio, and muscle mass), body mass index (BMI), and biochemical indices for nutritional assessment based on immunological and inflammatory markers. These nutritional status indices were the neutrophil-to-lymphocyte ratio (NLR) and the inflammatory-nutritional index (INI\u0026thinsp;=\u0026thinsp;the ratio of C-reactive protein and albumin).\u003c/p\u003e \u003cp\u003eFifteen human cytokine/chemokine markers, including granulocyte-macrophage colony-stimulating factor, interferon-gamma (IFN-γ), interleukin (IL)-1β, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p40, IL-12p70, IL-13, monocyte chemoattractant protein-1, and tumour necrosis factor-alpha (TNF-α), were analysed using multiplex quantification via Luminex xMAP technology (Luminex, Austin, TX, USA) to explore the immunomodulating effects of RBAC. The multiplexing analysis was conducted by Eve Technologies Corp. (Calgary, AB, Canada). Further details on the collection, storage, and analysis of the biological samples can be found in earlier publications (14, 15).\u003c/p\u003e \u003cp\u003ePatient safety was assessed with routine blood tests during cancer treatment, including complete blood count, liver function, electrolytes, urea, creatinine, and prealbumin. Adverse events reported by participants during clinical visits throughout the trial were also tracked and documented based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.\u003c/p\u003e \u003cp\u003eData on the participants\u0026rsquo; lifestyle factors were also collected using the Australian Eating Survey (AES) for dietary quality (19), the International Physical Activity Questionnaire (IPAQ) for physical activeness (20), and custom-designed Use of Complementary and Alternative Medicine Questionnaire (CAMQ) for usage and perceived value of complementary therapies (14). These lifestyle factors were assessed as potential confounding factors that might affect QoL. For more details on these lifestyle assessment questionnaires and the scoring methods, please refer to the study protocol (14) and interim analysis (15).\u003c/p\u003e \u003cp\u003eThe present study also included analysis of microbiota diversity (alpha diversity) and composition of different gut bacteria groups (beta diversity) between the RBAC and placebo groups as exploratory outcomes. The methods and results of faecal microbiome analysis based on 16S ribosomal RNA gene sequencing are complex and will be reported in a separate publication.\u003c/p\u003e \u003cp\u003eSample size\u003c/p\u003e \u003cp\u003eThe recruitment target was 50 participants with equal distribution in two groups. This sample size calculation was based on analysis of variance (ANOVA) with two groups and five repeated measures (RM), using a priori parameters with an alpha of 0.05, a power of 0.8, and an effect size of 0.35, resulting in a total sample size of 42. The effect size estimate of 0.35 was used according to the guidelines for sample size calculations for QLQ-C30 scores (21). The recruitment target was also consistent with sample size recommendations for a pilot study, as mentioned in the protocol (14).\u003c/p\u003e \u003cp\u003eRandomisation\u003c/p\u003e \u003cp\u003eConsented participants were screened based on the eligibility criteria before being randomly assigned to take either the RBAC or placebo intervention. The random allocation sequence was computer-generated using a stratified algorithm taking metastatic status (yes or no) and treatment (chemotherapy or immunotherapy) as inputs. The random allocation was done remotely by a researcher who did not interact with the participants. The patient, the treating oncologist, and the study coordinator were blinded to the actual content of the study intervention.\u003c/p\u003e \u003cp\u003eStatistical methods\u003c/p\u003e \u003cp\u003eDatasets were analysed with RStudio version 2024.09.0 Build 375 (Posit, Boston, MA, USA), running R version 4.4.0. Data analysis was based on the intention-to-treat principle. Every data point collected from participants in the trial was used regardless of withdrawal. Between-group comparisons over different time points were analysed with RM ANOVA. The F statistics with degrees of freedom, \u003cem\u003ep\u003c/em\u003e-value, and the effect size (generalised eta\u003csup\u003e2\u003c/sup\u003e) were reported for significant outcomes after sphericity correction. Values of eta\u003csup\u003e2\u003c/sup\u003e were interpreted as small (eta\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;\u0026ge;\u0026thinsp;0.01), medium (eta\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;\u0026ge;\u0026thinsp;0.06), and large (eta\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;\u0026ge;\u0026thinsp;0.14) effects.\u003c/p\u003e \u003cp\u003ePairwise comparisons were conducted when statistical significance was observed with the false discovery rates applied to adjust the \u003cem\u003ep\u003c/em\u003e-values for multiple comparisons. The effect sizes of the pairwise comparisons in Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e were also reported and interpreted as small (\u003cem\u003ed\u003c/em\u003e\u0026thinsp;\u0026ge;\u0026thinsp;0.2), medium (\u003cem\u003ed\u003c/em\u003e\u0026thinsp;\u0026ge;\u0026thinsp;0.5), and large (\u003cem\u003ed\u003c/em\u003e\u0026thinsp;\u0026ge;\u0026thinsp;0.8). Pearson\u0026rsquo;s correlation coefficient (\u003cem\u003er\u003c/em\u003e) was used to detect the strengths and directions of the relationships among the significant outcome variables. The strength of the \u003cem\u003er\u003c/em\u003e-coefficient was interpreted as non-significant (\u003cem\u003er\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.2), weak (0.2\u0026thinsp;\u0026ge;\u0026thinsp;\u003cem\u003er\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.4), moderate (0.4\u0026thinsp;\u0026ge;\u0026thinsp;\u003cem\u003er\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.6), strong (0.6\u0026thinsp;\u0026ge;\u0026thinsp;\u003cem\u003er\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.8), and very strong (\u003cem\u003er\u003c/em\u003e\u0026thinsp;\u0026ge;\u0026thinsp;0.8).\u003c/p\u003e \u003cp\u003eOutcome measures with data not conforming to normality were tested using nonparametric tests with ANOVA-type statistics utilising the npartLD R software package (22). Significance was based on the \u003cem\u003ep\u003c/em\u003e-value of the modified ANOVA-type statistic (mATS) after considering the whole-plot factors. The values of mATS with degrees of freedom and \u003cem\u003ep\u003c/em\u003e-values were reported, and the relative treatment effects (RTE) of both groups were compared at each visit for significant outcomes. RTE is a descriptive point estimator of the intervention effects under the rank-based nonparametric methods introduced by Brunner and Puri (23).\u003c/p\u003e \u003cp\u003eBetween-group comparisons were analysed for baseline characteristics and adverse events. Continuous variables were reported as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. The difference between any two means was analysed using two-sided Student\u0026rsquo;s t-statistics. Fisher\u0026rsquo;s exact test was used to determine if there were nonrandom associations between two categorical variables. A \u003cem\u003ep\u003c/em\u003e-value of less than or equal to 0.05 was considered statistically significant.\u003c/p\u003e \u003cp\u003eIf there were any significant between-group differences in the baseline characteristics or lifestyle factors, covariance analysis (ANCOVA) was to be performed on the significant outcomes in the primary analysis. The estimated marginal means of the outcome variables were calculated to adjust for any significant impact of the differences in baseline parameters, followed by pairwise comparisons to predict the differences after considering all confounding factors.\u003c/p\u003e"},{"header":"Results","content":"\u003ch2\u003eRecruitment flow\u003c/h2\u003e\n\u003cp\u003eRecruitment was conducted from June 2020 to December 2023, with interruptions during the COVID-19 pandemic. Follow-up with the last participant was completed in April 2024. The trial concluded short of the recruitment target due to resource and financial constraints. The participant flow report is presented in a CONSORT flowchart (24), depicted in Figure 1.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring recruitment, 62 potential participants from four study sites were identified. Thirty-six of them consented to participate and were screened for eligibility. Five did not meet the eligibility criteria, and one decided not to proceed with the trial after screening. The remaining 30 participants were randomly assigned to the two intervention groups (RBAC = 12, placebo = 18). Runs test for randomness (Wald-Wolfowitz test⁠)\u0026nbsp;on the allocation sequence yielded a \u003cem\u003ep\u003c/em\u003e-value of 0.441, indicating that the group allocation was random.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAfter randomisation, three participants withdrew their consent without receiving the allocated intervention. Two were from the placebo group, and one was from the RBAC group. Reasons for early withdrawal included physical injury, palliative care, and not being able to cope with additional tasks during cancer treatment.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring follow-up, one participant from the RBAC group dropped out due to rapidly progressing cancer and passed away two weeks into the trial. In contrast, seven participants from the placebo group discontinued the intervention. Their withdrawals resulted primarily from not being able to cope with protocol activities due to the side effects of conventional cancer treatment (\u003cem\u003en\u003c/em\u003e = 5). One patient was not responsive to standard immunotherapy and was placed on an experimental treatment, which precluded participation in any other trial. Another participant went into palliative care and passed away subsequently. Hence, 19 participants fully completed the trial: 10 in the RBAC group and 9 in the placebo group. Overall, among those who completed the trial, the compliance rate was high, averaging 99%, indicating the ease of consuming the oral supplements. \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll participants with at least some data collected were included in the intention-to-treat analysis. Only one participant from the placebo group was omitted, as the participant withdrew before providing any baseline data. Thus, data from 29 participants (RBAC = 12, placebo = 17) were analysed for the primary outcome. \u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eParticipant characteristics\u003c/h2\u003e\n\u003cp\u003eThe characteristics of both groups are shown in Table 1, comparing age, sex, body composition, cancer type, cancer stage, recurrence, metastasis, treatment type, lifestyle factors, and trial status. No significant differences were detected between the groups in baseline characteristics. Although the withdrawal rate appears higher in the placebo group (41.2%) than in the RBAC group (8.3%), the difference in frequency distribution did not reach statistical significance. \u0026nbsp;\u003c/p\u003e\n\u003ch2\u003ePrimary outcome analysis\u003c/h2\u003e\n\u003cp\u003eThe global QoL scale (QL2) was analysed with RM ANOVA and showed statistical differences between groups (F[1,15] = 5.67, \u003cem\u003ep\u003c/em\u003e = 0.031, eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.147). However, the effects of time and the interaction between time and group were not statistically significant. Pairwise comparisons of mean QL2 between groups for each time point are shown in Table 2. Clinically and statistically significant differences were observed at week 6 and week 24 with large effect sizes. At week 6, the RBAC group scored 75.8 ± 14.41 in mean QL2 compared to 57.6 ± 17.93 in the placebo group (\u003cem\u003ep\u003c/em\u003e = 0.017, Cohen’s \u003cem\u003ed\u003c/em\u003e = 1.118). The mean QL2 difference between RBAC and placebo at week 24 was 79.2 ± 19.74 and 57.41 ± 24.81, respectively (\u003cem\u003ep\u003c/em\u003e = 0.041, Cohen’s \u003cem\u003ed\u003c/em\u003e = 0.971).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFigure 2 shows the difference in mean QL2 scores between groups over time. The plot shows a dip in the global QoL of the placebo group at week 6, which recovered over the subsequent two visits before dropping again at the last visit (week 24). Conversely, the RBAC group showed an upward trend at week 6 and minor drops at weeks 12 and 18 before improvement at week 24. However, these differences over time were not statistically significant in pairwise comparison.\u003c/p\u003e\n\u003cp\u003eDatasets of the remaining 14 scales/items for QLQ-C30 did not fulfil the normality criterion of RM ANOVA and were analysed based on nonparametric tests with ANOVA-type statistics. The results are shown in Table 3.\u003c/p\u003e\n\u003cp\u003eAmong the five functional scales of QLQ-C30, statistical differences between groups were detected in role (RF2, \u003cem\u003ep\u003c/em\u003e \u0026lt; 0.001) and social functioning (SF, \u003cem\u003ep\u003c/em\u003e = 0.037). Meanwhile, the difference in cognitive functioning was marginally significant (CF, \u003cem\u003ep\u003c/em\u003e = 0.054). There was also a marginally significant difference between groups concerning financial difficulties (FI, \u003cem\u003ep\u003c/em\u003e = 0.058).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe RTE of both groups were compared at each visit for these functional scales, as visualised in Figure 3. The RBAC group demonstrated superior results compared to the placebo group on these functional scales, indicating a higher or healthier level of functioning in these domains. Most notably, participants taking RBAC reported significantly better role functioning (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05) than their placebo counterparts at every visit after baseline, most prominently at weeks 12 and 18 (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.01). The RBAC group also reported significantly higher social functioning than the placebo group at weeks 6 and 12. Pairwise comparisons in cognitive functioning found no significant differences between the groups over time. Worsening outcomes in functioning may have contributed to greater concerns over financial difficulties in the placebo group, as shown in Figure 3.\u003c/p\u003e\n\u003cp\u003eIn terms of symptom scores, significant between-group differences (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05) were detected for fatigue, pain, dyspnoea, and appetite loss. As shown in Figure 3, the placebo group exhibited higher RTE values than the RBAC group in each of these symptom measures, indicating a greater level of symptomatology or problems in these areas. Pairwise comparisons found significant differences between the groups at weeks 18 and 24 for dyspnoea (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05) and at week 12 for appetite loss (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.01).\u003c/p\u003e\n\u003ch2\u003eSecondary outcome analysis\u003c/h2\u003e\n\u003cp\u003eRM ANOVA was conducted on body weight, BMI, plus nutritional status indices of NLR and INI (See Supplementary S1). No statistically significant differences were detected between the groups at baseline and across all time points for these parameters. Therefore, this study was not able to explain the effect of RBAC on QoL beyond that of placebo based on the outcome measures.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eCytokine profile analysis\u003c/h2\u003e\n\u003cp\u003eCytokine profile analysis was an optional exploratory outcome measure for study sites due to additional logistics requirements for collecting, centrifuging, transporting and storing serum samples. Consequently, the cytokine profile analysis was performed with samples from only 19 participants (RBAC = 9, placebo = 10). Fourteen participants (7 in each group) fully completed the trial. Notwithstanding. among the 15 cytokines/chemokines analysed with RM ANOVA, three parameters yielded significant differences across time: IFN-γ\u0026nbsp;(F[4, 44] = 2.887, \u003cem\u003ep\u003c/em\u003e = 0.033, \u0026nbsp;eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.017), IL-1RA (F[4, 44] = 2.716, \u003cem\u003ep\u003c/em\u003e = 0.042, \u0026nbsp; eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.030), and IL-12p40 (F[4, 44] = 2.716, \u003cem\u003ep\u003c/em\u003e = 0.038, \u0026nbsp;eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.027). However, the effect sizes (eta\u003csup\u003e2\u003c/sup\u003e[g]) of the differences are considered small.\u003c/p\u003e\n\u003cp\u003eTable 4 shows the pairwise comparisons of the means of IFN-γ, IL-1RA, and IL-12p40 for the two groups across different time points. Due to the small effect sizes, no significant differences were detected for all measures at individual time points. Nonetheless, for IFN-γ, at week 18, the difference between RBAC and placebo groups was marginally significant (1.91 ± 0.20 vs. 1.69 ± 0.23,\u003cem\u003e\u0026nbsp;p\u0026nbsp;\u003c/em\u003e= 0.065). Overall, the RBAC group demonstrated slightly higher cytokine activities than the placebo group (Figure 4).\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eSafety outcome analysis\u003c/h2\u003e\n\u003cp\u003eThe study did not detect any safety issues in any of the participants based on routine clinical assessments, including complete blood count, liver function, electrolytes, urea, creatinine and prealbumin. Based on RM ANOVA analysis, three markers, namely white blood cell count (WBC), total protein (TP) and aspartate transferase (AST), showed significant differences. The WBC (F[4, 60] = 2.540, \u003cem\u003ep\u003c/em\u003e = 0.049, eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.071) and AST (F[4, 60] = 2.855, \u003cem\u003ep\u003c/em\u003e = 0.031, eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.040) were significantly different across time, whereas TP showed a significant interaction effect between group and time (F[4, 56] = 3.057, \u003cem\u003ep\u003c/em\u003e = 0.024, eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.051).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 5 shows the pairwise comparisons of the means of WBC, TP, and AST for the two groups across different time points. A significant difference in TP was observed at week 18, with the RBAC group showing 74.88 ± 6.81 g/L compared to 67.78 ± 5.36 g/L) in the placebo group (\u003cem\u003ep\u003c/em\u003e = 0.030, Cohen’s \u003cem\u003ed\u003c/em\u003e = 1.158). Trends in the WBC, TP, and AST for the two groups over time are visualised in Figure 5. Although time effects were detected as statistically significant with RM ANOVA, pairwise comparisons of different time points by groups did not yield any significant difference after the \u003cem\u003ep\u003c/em\u003e-values were corrected for multiplicity using FDR.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eCorrelations of significant outcomes\u003c/h2\u003e\n\u003cp\u003eTable 6 shows the pairwise correlation coefficients of the QL2, IFN-γ, IL-1RA, IL-12p40, WBC, AST, and TP as significant outcomes of this trial. A linear association between the global QoL of the participants (QL2) with IL-1RA (\u003cem\u003er\u003c/em\u003e = 0.245), IL-12p40 (\u003cem\u003er\u003c/em\u003e = 0.246) and TP (\u003cem\u003er\u003c/em\u003e = 0.310) was detected, demonstrating a positive link between QoL and the immune response (IFN-γ, IL-1RA, IL-12p40) and nutritional status (TP). IL-1RA and IL-12p40 exhibited a very high correlation (\u003cem\u003er\u003c/em\u003e = 0.907), indicating the interrelatedness of these two cytokines. Although the correlation between IFN-γ and QL2 was not significant (\u003cem\u003er\u003c/em\u003e = 0.168), the level of antitumour IFN-γ did exhibit strong correlations with both IL-1RA (\u003cem\u003er\u003c/em\u003e = 0.738) and IL-12p40 (\u003cem\u003er\u003c/em\u003e = 0.804). Moreover, the WBC level was also shown to correlate positively with TP (\u003cem\u003er\u003c/em\u003e = 0.407) and with the cytokines of IFN-γ (\u003cem\u003er\u003c/em\u003e = 0.211), IL-1RA (\u003cem\u003er\u003c/em\u003e = 0.205) and IL-12p40 (\u003cem\u003er\u003c/em\u003e = 0.200). These results suggest that cellular immunity plays a vital role in the observed improved QoL of the RBAC group over the placebo group. In contrast, the liver function test, AST, correlates negatively with IFN-γ (\u003cem\u003er\u003c/em\u003e = 0.240), IL1-RA (\u003cem\u003er\u003c/em\u003e = 0.270) and TP (\u003cem\u003er\u003c/em\u003e = 0.258).\u003c/p\u003e\n\u003ch2\u003eAnalysis of lifestyle factors\u003c/h2\u003e\n\u003cp\u003eRM ANOVA was applied to analyse the Australian Recommended Food Score (ARFS) derived from AES for diet assessment (19), metabolic equivalent of task (MET) score for physical activity and CAMQ score for usage and belief in complementary therapies. Analyses of ARFS and CAMQ scores were unremarkable (See Supplementary S1). Only the MET score showed a significant difference for time effect (F[4, 56] = 4.193, \u003cem\u003ep\u003c/em\u003e = 0.005, eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.134). However, pairwise comparisons between time points by group did not reveal any significant difference for both groups after adjustment for multiple comparisons. The differences in mean MET scores between time points also did not reach statistical significance after combining the data from all participants.\u003c/p\u003e\n\u003cp\u003eChanges in physical activity levels over time are illustrated in Figure 6. The participants had low to moderate levels of physical activity at the start of treatment (weeks 0 to 6) but became more active at weeks 12 and 18 (moderate to high) while slowing down at the end of their treatment (week 24). Both groups reported similar physical activity behaviours with no significant difference in MET score at any time point. Hence, physical activity level was not likely a confounding variable that could influence the between-group differences in the current research. \u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eAdjusted analysis\u003c/h2\u003e\n\u003cp\u003eAdjusted analysis with ANCOVA was not performed as there were no significant differences between groups in the participants’ baseline characteristics and lifestyle factors.\u003c/p\u003e\n\u003ch2\u003eAdverse events\u003c/h2\u003e\n\u003cp\u003eComparisons between the two groups regarding the adverse events reported during the trial period are shown in Table . The mean adverse events reported per participant in the RBAC group was lower at 2.33 ±3.22 compared to 4.59 ±2.87 in the placebo group, although the difference did not reach statistical significance (\u003cem\u003ep\u003c/em\u003e = 0.066).\u003c/p\u003e\n\u003cp\u003eAdverse events based on\u0026nbsp;the CTCAE classification were mostly mild (RBCA = 75.0%, placebo = 79.5%) and moderate (RBCA = 21.4%, placebo = 11.5%), with the grading distribution not significantly different between groups. Notwithstanding, there was one incident of life-threatening bowel obstruction in the placebo group where the patient was hospitalised. The event was resolved and deemed unlikely to be related to the study intervention. In the RBAC group, one death resulted from complications from a fast-growing malignancy unrelated to the study intervention two weeks after starting the trial. There was also a death incident in the placebo group; the participant missed visit 3 and subsequently withdrew from the trial due to a deteriorating condition and passed away one week later.\u003c/p\u003e\n\u003cp\u003eOverall, there was a significant difference in the distribution of the most commonly reported adverse events between groups (\u003cem\u003ep\u003c/em\u003e = 0.006). Fatigue was the most common adverse event reported in both groups (RBAC = 14.3%, placebo = 12.8%), followed by diarrhoea and nausea. Oral thrush and rash were reported in the placebo group, but not in the RBAC group. Other commonly reported adverse events include constipation, cough, peripheral neuropathy, pain, and shortness of breath. These adverse events were typical side-effects of oncological treatment and thus considered not related (RBAC = 53.6%, placebo = 70.5%) or unlikely to be related (RBAC = 42.9%, placebo = 26.9%) to the study interventions. Nonetheless, the oncologists rated three adverse events (diarrhoea, abdominal pain, and dysgeusia) as possibly study-related at the time of reporting, with one in the RBAC group and two in the placebo group. As these adverse events were mild and mostly resolved during the trial, they were subsequently deemed not likely to be caused by the study interventions. Overall, RBAC was considered as safe to consume. \u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis pilot study determined that RBAC improved patients\u0026rsquo; overall QoL during active cancer treatment, with a statistically significant difference compared to placebo. Notably, the mean global QoL scales of participants taking RBAC were significantly higher than those taking placebo at weeks 6 and 24, with effect size estimates (Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e) of 1.118 and 0.971, respectively. Based on the evidence-based guidelines by Cocks, King (21) for the interpretation of QLQ-C30, the effect size of cross-sectional differences in the global QoL for clinical relevance can be interpreted as small (0.2\u0026ndash;0.4), medium (0.4\u0026ndash;0.6), or large (\u0026gt;\u0026thinsp;0.6). Hence, the QoL differences observed in this study were considered large and thus clinically significant. Such favourable results in QoL maintenance with RBAC are consistent with the findings of Tan and Flores (25), who reported a statistically significant difference in the mean global QoL scales (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.019), favouring RBAC over placebo two months after radiation treatment in participants with head and neck cancers.\u003c/p\u003e \u003cp\u003eThe final results of global QoL scores are also consistent with those observed during the interim analysis (15), albeit with a marginally lower effect size estimate (0.147 vs. 0.267). Since the effect size statistic measures the variance of the sample rather than the population, it will tend to overestimate the effect size with a small sample and the bias is reduced with a larger cohort (26). Notably, a matched comparison of 33 interim-final analyses in oncology clinical trials reported that the effect sizes of final analyses were lower by a median of 31% compared to the effect sizes from interim analyses (27). Hence, a reduction in the effect size estimate in the present study is within expectation.\u003c/p\u003e \u003cp\u003eIn addition to improving global QoL, participants in the RBAC group reported significantly lower symptom severity for fatigue, pain, dyspnoea, and appetite loss compared to the placebo group, as measured by the EORTC QLQ-C30. RTE estimates indicated significantly greater reductions in these symptoms in the RBAC group compared to the placebo group at multiple time points, most notably for appetite loss at week 12 (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01) and dyspnoea at week 18 (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). This finding is supported by a marginally lower mean number of adverse events per participant in the RBAC group compared to the placebo group (2.33\u0026thinsp;\u0026plusmn;\u0026thinsp;3.22 vs. 4.59\u0026thinsp;\u0026plusmn;\u0026thinsp;2.87). These findings suggest that the relatively reduced symptom burden during cancer treatment may have contributed to improved role, social, and possibly cognitive functioning in the RBAC group as well as lowering the perceived cancer-related financial stress.\u003c/p\u003e \u003cp\u003eConsistent with these results, Masood, Sheikh (28) reported that breast cancer patients taking RBAC during six cycles of chemotherapy experienced fewer incidences of anorexia/tiredness, nausea/vomiting, alopecia, and weight loss compared to the control group who did not take RBAC. Similarly, Petrovics, Szigeti (29) demonstrated that in cancer patients with chronic fatigue syndrome, RBAC plus oncothermia, a specialised type of hyperthermia targeting tumours, significantly alleviated fatigue symptoms (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001) compared to the control group, during active treatment.\u003c/p\u003e \u003cp\u003eThe higher occurrence of adverse events and side effects from the cancer treatment led to a higher dropout in the placebo group in this study. Specifically, seven out of the 16 who received the placebo (43.75%) discontinued the trial, compared to only one out of 11 participants in the RBAC group (9.09%). The higher dropout rate in the placebo group could be partially due to the higher number of participants receiving chemotherapy treatment in the placebo (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;12) versus RBAC (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;7), as chemotherapy is known to be less tolerable than immunotherapy in advanced solid-organ malignancies (30). Five of the seven participants in the placebo group who dropped out were undergoing chemotherapy (one with stage IV cancer and four with stage III cancer).\u003c/p\u003e \u003cp\u003eThis disparity in attrition rates, despite the blinded design, raises potential concerns about the study's internal validity; however, it does not necessarily bias the results (31). In clinical research, lower health-related QoL values are known to be related to dropout and death. Most prominently, the global QoL scale, role functioning, physical functioning, and fatigue symptom score in the QLQ-C30 were key early dropout indicators, according to Gebert, Schindel (32). Hence, unequal dropout rates should be expected if one group has a significantly better QoL in a controlled trial.\u003c/p\u003e \u003cp\u003eAnother randomised controlled trial of RBAC also observed a considerable disparity in dropout rates, albeit in a different cancer patient group. Takahara and Sano (33) evaluated the adjunctive effects of RBAC on standard complementary and supportive care in people with progressive and metastasised cancer over 18 months. Of the 109 assigned to the control group, 53 (49%) patients dropped out due to increased intensity of cancer-related symptoms and did not survive at the end of the trial. In contrast, no dropout was observed in the RBAC group (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;96). The QoL scores improved in both groups among those who remained in the trial, but the RBAC group had a better increase in appetite. Thus, future trials of RBAC supplements should consider incorporating dropout rates due to adverse events as a formal outcome measure as it could be an indirect indicator for QoL.\u003c/p\u003e \u003cp\u003eNutritional status strongly predicts QoL in cancer patients (34). However, no significant between-group differences in body composition parameters and nutritional status indices (INI and NLR) were detected in this study. The discordance could be due to the small sample size, the heterogeneity in cancer types, and the aptness of the chosen outcome measures. Notwithstanding, the present research revealed significant differences in TP between RBAC and the placebo group with a medium effect size. Specifically, the RBAC group showed a significantly higher TP level at week 18 compared to the placebo group, even though TP levels of both groups remained within the normal range. Furthermore, TP and global QoL scores showed a positive correlation. Chemotherapy is known to lower serum TP due to its toxicity (35). An improved TP level in the present study suggests that RBAC could better preserve the hepatic and renal function during treatment contributing to better QoL. Serum TP level, along with its components of albumin and globulin and their ratio (A/G ratio), has been suggested as markers for protein-energy malnutrition by Rahman and Begum (36). However, this study found no significant between-group differences in albumin level and A/G ratio over time. Thus, the impact of RBAC on the nutritional status of cancer patients during treatment remains unclear and needs further investigation.\u003c/p\u003e \u003cp\u003eIn the previous interim analysis of the same trial (15), there was also a significant difference in WBC between group and time. Additionally, the TP level was strongly correlated with WBC. This final analysis, however, yields a much weaker correlation between TP and WBC, and thus does not support the proposition that RBAC could potentially improve QoL through preserving WBC level and nutritional status. Hence, further research is required to explore the underlying mechanisms that influence the QoL enhancement effect of RBAC in cancer patients. For example, the inflammatory-induced tryptophan-kynurenine pathway linked to fatigue, depression, and decreased QoL in patients with solid tumours can be a potential candidate for investigation in future studies (37).\u003c/p\u003e \u003cp\u003eTwo earlier studies reported that RBAC could modulate the cytokine profile of cancer patients. Cholujova, Jakubikova (38) reported that the plasma concentrations of both the Th1 (IL-12, IL-17, TNF-α, and INF-γ) and Th2 (IL-4, IL-6, IL-9, IL-10, and IL-13) cytokines in multiple myeloma patients were significantly elevated (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05) by RBAC (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;32) compared to placebo (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;16) after three months in a randomised controlled trial. In another non-randomised trial, Kim, Hong (39) also reported that cancer patients (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;10) who consumed an oral nutritional supplement containing 0.4 g of rice bran bio-exopolymer, a variation of RBAC, had significantly lower levels of IL-1β, IL-6, and IL-8 and a higher level of IL-12p70 (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05) compared to a control group (\u003cem\u003en\u003c/em\u003e\u0026thinsp;=\u0026thinsp;24) receiving nutritional counselling only.\u003c/p\u003e \u003cp\u003eThe current study also found evidence of cytokine modulation by RBAC with significant differences in IFN-γ, IL-1RA, and IL-12p40 over time between RBAC and placebo groups. The RBAC group appeared to have elevated levels of these cytokines compared to the placebo group. Moreover, these cytokines showed positive correlations with global QoL and WBC. IFN-γ is a pleiotropic cytokine produced mainly by NK cells and NK T cells, which exhibited antitumour, antiviral, and immunomodulatory functions (40). An animal study by Badr El-din, Noaman (41) showed that tumour-bearing mice treated with RBAC had significantly higher IFN-γ levels (154.54%) that contributed to significantly lower tumour volume (63.27%) and tumour weight (45.2%) as compared to controls (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01).\u003c/p\u003e \u003cp\u003eIL-1RA is an anti-inflammatory cytokine that counteracts tumour growth and promotes malignant cell apoptosis through the IL-1 signalling pathway. As such, IL-1RA therapy has been used as an anticancer adjuvant to augment the therapeutic efficacies of chemotherapy and immunotherapy (42). IL-12p40 is a subunit of the IL-12 cytokine produced by dendritic cells to activate the Th1 response and stimulate NK cells to secret IFN-γ (43). In colorectal cancer patients, circulating IL-12p40 levels decreased significantly with disease progression (44). Hence, the elevated levels of IFN-γ, IL-1RA, and IL-12p40 in the RBAC group could result from the immunomodulatory effects of RBAC, particularly through inducing dendritic cell maturation, upregulating NK cell activity, promoting tumour cell apoptosis as previously described in the literature (11, 45).\u003c/p\u003e \u003cp\u003eIt should be noted that the effect size estimates of IFN-γ, IL-1RA, and IL-12p40 were small, and no significant differences were detected in post-hoc analysis with pairwise comparisons. The cytokine profile analysis was an optional trial component performed on a subset of participants (19 out of 29). Due to the limited sample size and small effects, this pilot trial has insufficient power to detect the between-group differences in cytokine profiles at each time point. Therefore, the impact of RBAC intervention on cytokine profiles during active cancer treatment observed in this study is suggestive and should be validated in future research.\u003c/p\u003e \u003cp\u003eThis pilot study aimed to inform the design of a large-scale clinical trial. Based on the effect size (eta2[g]) of 0.147 for the global QoL scale, a sufficiently powered study needs a sample size of 88 to achieve the estimated power of 95% based on the a priori power analysis of RM ANOVA (2 groups and 5 measurements, α\u0026thinsp;=\u0026thinsp;0.5, 1-β\u0026thinsp;=\u0026thinsp;0.95) for within-between interactions. However, anticipating an unequal dropout rate between groups, the future trial should target to recruit up to 115 participants, randomly allocating 66 (~\u0026thinsp;40% extra) in the placebo group and 49 (~\u0026thinsp;10% extra) in the RBAC group based on an allocation ratio of approximately 1.35 (placebo) to 1 (RBAC).\u003c/p\u003e \u003cp\u003eThis study has several limitations. The most notable is the small sample size, which necessitates validation of the results with a larger study. The short trial duration (6 months) also offers no opportunity to observe the participants\u0026rsquo; QoL posttreatment. Thus, it is unclear how long the QoL-improving effects of RBAC could last. Additionally, the lack of posttreatment follow-up also renders no outcome data for validating whether RBAC treatment could improve the survival odds of cancer patients. Nonetheless, the positive findings provide valuable insights into the therapeutic potential of RBAC in cancer treatment and lay the foundation for further translational research of RBAC.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThe RBAC-QoL study showed favourable results, indicating that RBAC improves the QoL for cancer patients undergoing active treatment. Compared to the placebo group, participants in the RBAC group reported better global QoL scores and significantly lower rates of fatigue, pain, dyspnoea, and appetite loss. RBAC was safe to consume with no known adverse effects. The observed reduction in symptoms experienced during cancer treatment also led to better role and social functioning. Additionally, significant increases in serum TP, IFN-γ, IL-1RA, and IL-12p40 were observed in the RBAC group over time, and the TP, IL-1RA, and IL-12p40 showed positive correlations with the global QoL scales. These findings suggest potential interactions between nutritional status, immune modulation, and QoL. However, with a small sample size, the findings should be interpreted cautiously and cannot be relied on as evidence of treatment efficacies. Regardless, this analysis provides valuable information and justification for a larger clinical trial to confirm RBAC\u0026rsquo;s beneficial effects on cancer patients\u0026rsquo; QoL.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eThe following abbreviations are used in this manuscript:\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eAES\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eAustralian Eating Survey\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eANOVA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eAnalysis of variance\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eANCOVA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eCovariance analysis\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eARFS\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eAustralian Recommended Food Score\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eBMI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eBody mass index\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eCAMQ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eUse of Complementary and Alternative Medicine Questionnaire\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eCONSORT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eConsolidated Standards of Reporting Trials\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eCr\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eCreatinine\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eCTCAE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eCommon Terminology Criteria for Adverse Events\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eEORTC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eEuropean Organisation for the Research and Treatment of Cancer\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eHREC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eHuman Research Ethics Committee\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eIFN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eInterferon\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eIL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eInterleukin\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eINI\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eInflammatory-nutritional index\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eIPAQ\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eInternational Physical Activity Questionnaire\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003emATS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003emodified ANOVA-type statistic\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eMET\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eMetabolic equivalent of task\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eNK\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eNatural killer\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eNLR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eNeutrophil-to-lymphocyte ratio\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eQL2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eGlobal QoL scale\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eQLQ-C30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eCore 30-item QoL questionnaire\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eQoL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eQuality of life\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eRBAC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eRice bran arabinoxylan compound\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eRM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eRepeated measures\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eRNA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eRibonucleic acid\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eRTE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eRelative treatment effects\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eTNF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eTumour necrosis factor-alpha\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eTP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eTotal protein\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003eWBC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 507px;\"\u003e\n \u003cp\u003eWhite blood cell count\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThis study was approved by the Human Research Ethics Committee (HREC) of Concord Repatriation General Hospital, Sydney Local Health District (Application No. 2019/ ETH00489) and Charles Sturt University HREC (Protocol No. H19244) All participants in the study provided written informed consent before starting the trial. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eThe manuscript has been read and approved by all named authors, and there are no other persons who satisfied the criteria for authorship but are not listed. All authors had agreed to the publication. The manuscript contains no participant’s personal data in any form.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eThe datasets generated and/or analysed during the current study are not publicly available due to commercial funding agreement but are available from the corresponding author for non-commercial research use on reasonable request.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eAll authors have no conflicts of interest to declare.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThis clinical trial is funded by Daiwa Pharmaceutical Co., Ltd. (Japan) and BioMedica Nutraceuticals Pty Ltd. (Australia).\u0026nbsp;The funding bodies were not involved in study design, data collection, management, analysis, interpretation, or the decision to submit for publication.\u003c/p\u003e\n\u003ch2\u003eAuthor contributions\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eSLO\u003c/strong\u003e: Conceptualisation, Methodology, Software, Formal analysis, Investigation, Data Curation, Writing - Original Draft, Visualisation. \u003cstrong\u003ePSM:\u0026nbsp;\u003c/strong\u003eConceptualisation, Methodology, Validation, Writing - Review \u0026amp; Editing. \u003cstrong\u003eRZ\u003c/strong\u003e: Conceptualisation, Methodology, Investigation, Validation, Resources, Writing - Review \u0026amp; Editing. \u003cstrong\u003eSCP\u003c/strong\u003e: Conceptualisation, Methodology, Validation, Resources, Writing - Review \u0026amp; Editing, Supervision, Project administration. \u003cstrong\u003eJL\u003c/strong\u003e: \u0026nbsp;Resources, Writing - Review \u0026amp; Editing. \u003cstrong\u003eSK\u003c/strong\u003e: Investigation, Resources, Writing - Review \u0026amp; Editing. \u003cstrong\u003eSG\u003c/strong\u003e, \u003cstrong\u003eTG\u003c/strong\u003e: Writing - Review \u0026amp; Editing.\u003c/p\u003e\n\u003ch2\u003eAcknowledgement\u003c/h2\u003e\n\u003cp\u003eThe authors acknowledge the assistance of Emily Schupfer, Tegan Grosfeld, and Ki Kwon in trial coordination and data collection for this study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSLO acknowledges support through the Australian Government Research Training Program scholarship for his PhD study. This study contributed toward the Ph.D. degree for SLO.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eFerlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer; 2024 [Available from: https://gco.iarc.who.int/today.\u003c/li\u003e\n\u003cli\u003eBray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2024;74(3):229\u0026thinsp;\u0026minus;\u0026thinsp;63.\u003c/li\u003e\n\u003cli\u003eTamburini M, Casali PG, Miccinesi G. Outcome assessment in cancer management. Surgical Clinics of North America. 2000;80(2):471\u0026thinsp;\u0026minus;\u0026thinsp;86.\u003c/li\u003e\n\u003cli\u003ePalumbo MO, Kavan P, Miller W, Panasci L, Assouline S, Johnson N, et al. Systemic cancer therapy: achievements and challenges that lie ahead. Frontiers in Pharmacology. 2013;4:57.\u003c/li\u003e\n\u003cli\u003eKatta B, Vijayakumar C, Dutta S, Dubashi B, Nelamangala Ramakrishnaiah VP. The incidence and severity of patient-reported side effects of chemotherapy in routine clinical care: A prospective observational study. Cureus. 2023;15(4):e38301.\u003c/li\u003e\n\u003cli\u003eFirkins J, Hansen L, Driessnack M, Dieckmann N. Quality of life in \u0026ldquo;chronic\u0026rdquo; cancer survivors: a meta-analysis. Journal of Cancer Survivorship. 2020;14(4):504\u0026thinsp;\u0026minus;\u0026thinsp;17.\u003c/li\u003e\n\u003cli\u003eJitender S, Mahajan R, Rathore V, Choudhary R. Quality of life of cancer patients. Journal of Experimental Therapeutics and Oncology. 2018;12(3):217\u0026thinsp;\u0026minus;\u0026thinsp;21.\u003c/li\u003e\n\u003cli\u003eNguyen LB, Vu LG, Le TT, Nguyen XT, Dao NG, Nguyen DC, et al. Impact of interventions on the quality of life of cancer patients: a systematic review and meta-analysis of longitudinal research. Health and Quality of Life Outcomes. 2023;21(1):112.\u003c/li\u003e\n\u003cli\u003eNolazco JI, Chang SL. The role of health-related quality of life in improving cancer outcomes. Journal of Clinical and Translational Research. 2023;9(2):110-4.\u003c/li\u003e\n\u003cli\u003eOlver I, Keefe D, Herrstedt J, Warr D, Roila F, Ripamonti CI. Supportive care in cancer\u0026mdash;a MASCC perspective. Supportive Care in Cancer. 2020;28(8):3467-75.\u003c/li\u003e\n\u003cli\u003eOoi SL, Micalos PS, Kim J, Pak SC. Rice bran arabinoxylan compound as a natural product for cancer treatment \u0026ndash; an evidence-based assessment of the effects and mechanisms. Pharmaceutical Biology. 2024;62(1):367\u0026thinsp;\u0026minus;\u0026thinsp;93.\u003c/li\u003e\n\u003cli\u003eOoi SL, McMullen D, Golombick T, Pak SC. Evidence-based review of BioBran/MGN-3 arabinoxylan compound as a complementary therapy for conventional cancer treatment. Integrative Cancer Therapies. 2018;17(2):165\u0026thinsp;\u0026minus;\u0026thinsp;78.\u003c/li\u003e\n\u003cli\u003eOoi SL, Pak SC, Micalos PS. Health-related quality of life. In: Pak SC, Ooi SL, Micalos PS, Ghoneum MH, editors. Modified rice bran arabinoxylan: Therapeutic applications in cancer and other diseases. Singapore: Springer Nature; 2023. p. 87\u0026ndash;99.\u003c/li\u003e\n\u003cli\u003eOoi SL, Pak SC, Micalos PS, Schupfer E, Zielinski R, Jeffries T, et al. Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial. Contemporary Clinical Trials Communications. 2020;19:100580.\u003c/li\u003e\n\u003cli\u003eOoi SL, Micalos PS, Zielinski R, Pak SC. Rice bran arabinoxylan compound and quality of life (RBAC-QoL) of cancer patients: An interim analysis of the RBAC-QoL Study. Cureus. 2024;16(1):e53188.\u003c/li\u003e\n\u003cli\u003eThe National Clinical Trials Governance Framework and User Guide for Health Service Organisations Conducting Clinical Trials. Sydney, Australia: Australia Government Department of Health; 2022.\u003c/li\u003e\n\u003cli\u003eSchulz KF, Altman DG, Moher D, the CG. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Medicine. 2010;8(1):18.\u003c/li\u003e\n\u003cli\u003eFayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, et al. EORTC QLQ-C30 scoring manual. Brussels, Belgium: European Organisation for Research and Treatment of Cancer,; 2001.\u003c/li\u003e\n\u003cli\u003eCollins CE, Burrows TL, Rollo ME, Boggess MM, Watson JF, Guest M, et al. The comparative validity and reproducibility of a diet quality index for adults: The Australian Recommended Food Score. Nutrients. 2015;7(2):785\u0026thinsp;\u0026minus;\u0026thinsp;98.\u003c/li\u003e\n\u003cli\u003eLee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the international physical activity questionnaire short form (IPAQ-SF): A systematic review. International Journal of Behavioral Nutrition and Physical Activity. 2011;8(1):115.\u003c/li\u003e\n\u003cli\u003eCocks K, King MT, Velikova G, Martyn St-James M, Fayers PM, Brown JM. Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Journal of Clinical Oncology. 2011;29(1):89\u0026ndash;96.\u003c/li\u003e\n\u003cli\u003eNoguchi K, Gel YR, Brunner E, Konietschke F. nparLD: An R software package for the nonparametric analysis of longitudinal data in factorial experiments. Journal of Statistical Software. 2012;50(12):1\u0026ndash;23.\u003c/li\u003e\n\u003cli\u003eBrunner E, Puri ML. Nonparametric methods in factorial designs. Statistical Papers. 2001;42(1):1\u0026ndash;52.\u003c/li\u003e\n\u003cli\u003eFalci SG, Marques LS. CONSORT: when and how to use it. Dental Press Journal of Orthodontics. 2015;20(3):13\u0026thinsp;\u0026minus;\u0026thinsp;5.\u003c/li\u003e\n\u003cli\u003eTan DFS, Flores JAS. The immunomodulating effects of arabinoxylan rice bran ( Lentin ) on hematologic profile, nutritional status and quality of life among head and neck carcinoma patients undergoing radiation therapy: A double blind randomized control trial. Radiology Journal, The Official Publication of the Philippine College of Radiology [Internet]. 2020; 12(February):[11\u0026thinsp;\u0026minus;\u0026thinsp;6 pp.]. Available from: https://philippinecollegeofradiology.org.ph/wppcr/wp-content/uploads/Radiology-Journal-2020.pdf.\u003c/li\u003e\n\u003cli\u003eOlejnik S, Algina J. Generalized eta and omega squared statistics: measures of effect size for some common research designs. Psychological Methods. 2003;8(4):434\u0026thinsp;\u0026minus;\u0026thinsp;47.\u003c/li\u003e\n\u003cli\u003eWayant C, Vassar M. A comparison of matched interim analysis publications and final analysis publications in oncology clinical trials. Annals of Oncology. 2018;29(12):2384-90.\u003c/li\u003e\n\u003cli\u003eMasood AI, Sheikh R, Anwer RA. \u0026ldquo;BIOBRAN MGN-3\"; effect of reducing side effects of chemotherapy in breast cancer patients. The Professional Medical Journal [Internet]. 2013; 20(1):[13\u0026thinsp;\u0026minus;\u0026thinsp;6 pp.]. Available from: http://www.theprofesional.com/index.php/tpmj/article/view/4869.\u003c/li\u003e\n\u003cli\u003ePetrovics G, Szigeti G, Hamvas S, Mate A, Betlehem J, Hegyi G. Controlled pilot study for cancer patients suffering from chronic fatigue syndrome due to chemotherapy treated with BioBran (MGN-3 Arabinoxylane) and targeted radiofrequency heat therapy. European Journal of Integrative Medicine. 2016;8:29\u0026ndash;35.\u003c/li\u003e\n\u003cli\u003eMagee DE, Hird AE, Klaassen Z, Sridhar SS, Nam RK, Wallis CJD, et al. Adverse event profile for immunotherapy agents compared with chemotherapy in solid organ tumors: a systematic review and meta-analysis of randomized clinical trials. Annals of Oncology. 2020;31(1):50\u0026ndash;60.\u003c/li\u003e\n\u003cli\u003eBell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013;346:e8668.\u003c/li\u003e\n\u003cli\u003eGebert P, Schindel D, Frick J, Schenk L, Grittner U. Characteristics and patient-reported outcomes associated with dropout in severely affected oncological patients: an exploratory study. BMC Medical Research Methodology. 2021;21(1):77.\u003c/li\u003e\n\u003cli\u003eTakahara K, Sano K. The life prolongation and QOL improvement effect of rice bran arabinoxylan derivative (MGN-3, Biobran) for progressive cancer. Clinical Pharmacology and Therapy. 2004;14(3):267\u0026ndash;71.\u003c/li\u003e\n\u003cli\u003eLis CG, Gupta D, Lammersfeld CA, Markman M, Vashi PG. Role of nutritional status in predicting quality of life outcomes in cancer \u0026ndash; a systematic review of the epidemiological literature. Nutrition Journal. 2012;11(1):27.\u003c/li\u003e\n\u003cli\u003eAbbasi B, Hayat A, Lyons M, Gupta A, Gupta S. Serum protein and electrolyte imbalances are associated with chemotherapy induced neutropenia. Heliyon. 2022;8(7).\u003c/li\u003e\n\u003cli\u003eRahman MZ, Begum BA. Serum total protein, albumin and A/G ratio in different grades of protein energy malnutrition. Mymensingh Medical Journal. 2005;14(1):38\u0026ndash;40.\u003c/li\u003e\n\u003cli\u003eLanser L, Kink P, Egger EM, Willenbacher W, Fuchs D, Weiss G, et al. Inflammation-induced tryptophan breakdown is related with anemia, fatigue, and depression in cancer. Frontiers in Immunology. 2020;11:249.\u003c/li\u003e\n\u003cli\u003eCholujova D, Jakubikova J, Czako B, Martisova M, Hunakova L, Duraj J, et al. MGN-3 arabinoxylan rice bran modulates innate immunity in multiple myeloma patients. Cancer Immunol Immunother. 2013;62(3):437\u0026ndash;45.\u003c/li\u003e\n\u003cli\u003eKim JM, Hong SG, Song BS, Sohn HJ, Baik H, Sung MK. Efficacy of cereal-based oral nutrition supplement on nutritional status, inflammatory cytokine secretion and quality of life in cancer patients under cancer therapy. Journal of Cancer Prevention. 2020;25(1):55\u0026ndash;63.\u003c/li\u003e\n\u003cli\u003eJorgovanovic D, Song M, Wang L, Zhang Y. Roles of IFN-\u0026gamma; in tumor progression and regression: A review. Biomarker Research. 2020;8(1):49.\u003c/li\u003e\n\u003cli\u003eBadr El-din NK, Noaman E, Ghoneum M. In vivo tumor inhibitory effects of nutritional rice bran supplement MGN-3/Biobran on Ehrlich carcinoma-bearing mice. Nutrition and Cancer. 2008;60(2):235\u0026ndash;44.\u003c/li\u003e\n\u003cli\u003eFang Z, Jiang J, Zheng X. Interleukin-1 receptor antagonist: An alternative therapy for cancer treatment. Life Sciences. 2023;335:122276.\u003c/li\u003e\n\u003cli\u003eShemesh A, Pickering H, Roybal KT, Lanier LL. Differential IL-12 signaling induces human natural killer cell activating receptor-mediated ligand-specific expansion. Journal of Experimental Medicine. 2022;219(8):e20212434.\u003c/li\u003e\n\u003cli\u003eStanilov N, Miteva L, Jovchev J, Cirovski G, Stanilova S. The prognostic value of preoperative serum levels of IL-12p40 and IL-23 for survival of patients with colorectal cancer. APMIS. 2014;122(12):1223-9.\u003c/li\u003e\n\u003cli\u003eOoi SL, Pak SC, Micalos PS, Schupfer E, Lockley C, Park MH, et al. The health-promoting properties and clinical applications of rice bran arabinoxylan modified with shiitake mushroom enzyme \u0026ndash; a narrative review. Molecules. 2021;26(9):2539.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1. Participant characteristics\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"595\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 312px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRBAC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 312px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eN (available for analysis)\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e12 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e17 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eAge\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e68.8\u0026nbsp;\u0026plusmn;9.17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e64.1\u0026nbsp;\u0026plusmn;7.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.152\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSex\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e7 (58.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e14 (83.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.218\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e5 (41.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e3 (17.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eBody Composition\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eWeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e79.0 \u0026plusmn;24.38\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e86.2 \u0026plusmn;18.26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.381\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eBody Mass Index\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e27.6 \u0026plusmn;7.79\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e27.6 \u0026plusmn;4.67\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.988\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrimary Cancer\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eLung\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e2 (16.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e6 (35.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.268\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eMelanoma\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e4 (33.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e2 (11.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eColon and Rectum\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e4 (23.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eOvary and Uterus\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e3 (25.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1 (5.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eBladder\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eStomach\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eBreast\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1 (5.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eOesophagus\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1 (5.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003ePleura\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1 (5.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eKidney\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1 (5.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eCancer Stage\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (8.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1 (5.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.847\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e4 (33.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e8 (47.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e7 (58.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e8 (47.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eRecurrence\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e7 (58.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e11 (64.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 1.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e5 (41.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e6 (32.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eMetastasis\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e2 (16.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e4 (23.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 1.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e10 (83.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e13 (76.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eTreatment\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eChemotherapy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e7 (58.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e12 (70.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.694\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eImmunotherapy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e5 (41.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e5 (29.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eLifestyle Factors\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eDiet (ARFS)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e30.7\u0026nbsp;\u0026plusmn;8.51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e33.5\u0026nbsp;\u0026plusmn;8.74\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.456\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003ePhysical Activity (MET/week)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e830.3\u0026nbsp;\u0026plusmn;601.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e706.5\u0026nbsp;\u0026plusmn;639.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.399\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eCAMQ Score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e15.8\u0026nbsp;\u0026plusmn;12.74\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e11.1\u0026nbsp;\u0026plusmn;12.41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.493\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrial Status\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eWithdrawn\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e7 (41.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.105\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eDeceased\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e1 (5.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 123px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003eCompleted\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e10 (83.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e9 (52.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 595px;\"\u003e\n \u003cp\u003eAll continuous variables are presented as mean\u0026nbsp;\u0026plusmn; standard deviation, and the hypothesis testing of two means was based on the two-sided Student\u0026rsquo;s t-test. Significant testing of categorical variables was determined using Fisher\u0026rsquo;s exact test. ARFS = Australian recommended food score; CAMQ= Use of complementary and alternative medicine questionnaire; MET = metabolic equivalent of task; RBAC = rice bran arabinoxylan compound.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 3. Pairwise comparisons of mean global quality of life score (QL2) between groups over time.\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"586\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVisit\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVariable (unit)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRBAC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 (Baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003eQL2 (1-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e70.8\u0026nbsp;\u0026plusmn;\u0026nbsp;21.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e60.0\u0026nbsp;\u0026plusmn; 19.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e0.156\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e0.533\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (Week 6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003eQL2 (1-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e75.8\u0026nbsp;\u0026plusmn; 14.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e57.6\u0026nbsp;\u0026plusmn; 17.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.017 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1.118\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2 (Week 12)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003eQL2 (1-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e73.1\u0026nbsp;\u0026plusmn; 14.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e66.7\u0026nbsp;\u0026plusmn; 13.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e0.315\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e0.457\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 (Week 18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003eQL2 (1-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e70.4\u0026nbsp;\u0026plusmn; 12.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e63.89\u0026nbsp;\u0026plusmn;\u0026nbsp;19.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e0.486\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e0.394\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4 (Week 24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003eQL2 (1-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e79.2\u0026nbsp;\u0026plusmn; 19.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e57.41\u0026nbsp;\u0026plusmn; 24.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.041 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.971\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 586px;\"\u003e\n \u003cp\u003e^ Statistically significant difference between two means based on the two-sided Student\u0026rsquo;s t-test with \u003cem\u003ep\u0026nbsp;\u003c/em\u003e\u0026le;\u0026nbsp;0.05 (with multiplicity adjusted with false discovery rate). RBAC = rice bran arabinoxylan compound.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 3. The modified ANOVA-type statistic based on the group effect for 14 QLQ-C30 scales/items\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"539\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eScale/Item\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e\u003cstrong\u003emATS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDf1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDf2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePhysical Functioning (PF2)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e2.36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e18.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0.141\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRole Functioning (RF2)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e22.21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e19.85\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026lt; 0.001 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEmotional Functioning (EF)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e0.09\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e18.82\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0.767\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCognitive Functioning (CF)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e4.17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e19.49\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0.054 \u003csup\u003e+\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSocial Functioning (SF)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e4.99\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e19.41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.037 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFatigue (FA)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e4.59\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e19.17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.045 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNausea \u0026amp; Vomiting (NV)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e\u0026lt; 0.01\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e18.16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0.967\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePain (PA)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e4.43\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e19.42\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.048 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDyspnoea (DY)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e4.53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e18.49\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.047 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eInsomnia (SL)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e0.45\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e19.96\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0.508\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAppetite Loss (AP)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e4.64\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e20.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.044 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eConstipation (CO)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e0.06\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e19.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0.804\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDiarrhoea (DI)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e0.80\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e13.91\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0.387\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFinancial Difficulties (FI)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e4.25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e13.71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 72px;\"\u003e\n \u003cp\u003e0.058 \u003csup\u003e+\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 539px;\"\u003e\n \u003cp\u003e* The statistically significant difference between groups (RBAC vs. Placebo) was based on the modified ANOVA-type statistic for the whole-plot factors (mATS) with \u003cem\u003ep\u0026nbsp;\u003c/em\u003e\u0026le; 0.05. \u003csup\u003e+\u003c/sup\u003e Marginal significance \u003cem\u003ep\u0026nbsp;\u003c/em\u003e\u0026asymp;\u0026nbsp;0.05. Df = Degree of freedom; RBAC = rice bran arabinoxylan compound.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 4. Pairwise comparisons of interferon-gamma (IFN-\u0026gamma;), interleukin-1RA (IL-1RA), and interleukin-12p40 (IL-12p40) between groups over time.\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"602\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVisit\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVariable (unit)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRBAC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 (Baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIFN-\u0026gamma;\u0026nbsp;(pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.86\u0026nbsp;\u0026plusmn;\u0026nbsp;0.21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.70\u0026nbsp;\u0026plusmn; 0.26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.164\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.673\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (Week 6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIFN-\u0026gamma;\u0026nbsp;(pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.84\u0026nbsp;\u0026plusmn; 0.22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.76\u0026nbsp;\u0026plusmn; 0.19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.468\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.400\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2 (Week 12)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIFN-\u0026gamma;\u0026nbsp;(pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.91\u0026nbsp;\u0026plusmn; 0.20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.69\u0026nbsp;\u0026plusmn; 0.23\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.065\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.019\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 (Week 18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIFN-\u0026gamma;\u0026nbsp;(pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.86\u0026nbsp;\u0026plusmn; 0.30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.66\u0026nbsp;\u0026plusmn;\u0026nbsp;0.21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.147\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.786\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4 (Week 24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIFN-\u0026gamma;\u0026nbsp;(pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.92\u0026nbsp;\u0026plusmn; 0.28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.74\u0026nbsp;\u0026plusmn; 0.20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.186\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.714\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 (Baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-1RA (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.70 \u0026plusmn; 0.06\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.69\u0026nbsp;\u0026plusmn; 0.08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.703\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.179\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (Week 6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-1RA (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.73\u0026nbsp;\u0026plusmn; 0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.68\u0026nbsp;\u0026plusmn; 0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.195\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.762\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2 (Week 12)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-1RA (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.72\u0026nbsp;\u0026plusmn; 0.06\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.67\u0026nbsp;\u0026plusmn; 0.08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.166\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.752\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 (Week 18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-1RA (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.71\u0026nbsp;\u0026plusmn; 0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.67\u0026nbsp;\u0026plusmn; 0.08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.360\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.493\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4 (Week 24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-1RA (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.74\u0026nbsp;\u0026plusmn; 0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.70\u0026nbsp;\u0026plusmn; 0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.157\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.780\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 (Baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-12p40 (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.34 \u0026plusmn; 0.06\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.34\u0026nbsp;\u0026plusmn; 0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.887\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.067\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (Week 6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-12p40 (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.35\u0026nbsp;\u0026plusmn; 0.06\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.31\u0026nbsp;\u0026plusmn; 0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.297\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.592\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2 (Week 12)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-12p40 (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.37\u0026nbsp;\u0026plusmn; 0.06\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.31\u0026nbsp;\u0026plusmn; 0.09\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.168\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.750\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 (Week 18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-12p40 (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.37\u0026nbsp;\u0026plusmn; 0.06\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.33\u0026nbsp;\u0026plusmn; 0.08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.308\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.556\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4 (Week 24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 114px;\"\u003e\n \u003cp\u003eIL-12p40 (pg/ml)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 93px;\"\u003e\n \u003cp\u003e1.37\u0026nbsp;\u0026plusmn; 0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e1.34\u0026nbsp;\u0026plusmn; 0.08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.523\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.345\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 602px;\"\u003e\n \u003cp\u003e* The statistically significant difference between the two means is based on the two-sided Student\u0026rsquo;s t-test with \u003cem\u003ep\u0026nbsp;\u003c/em\u003e\u0026le; 0.05\u0026nbsp;(multiplicity adjusted with false discovery rate). RBAC = rice bran arabinoxylan compound.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 5. Pairwise comparisons of white blood cell count (WBC), total protein (TP), and transferase (AST) between groups over time.\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"602\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVisit\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVariable (unit)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRBAC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 (Baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eWBC (x10\u003csup\u003e9\u003c/sup\u003e/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e5.86\u0026nbsp;\u0026plusmn;\u0026nbsp;2.25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e6.01\u0026nbsp;\u0026plusmn; 1.91\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.844\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e-0.074\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (Week 6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eWBC (x10\u003csup\u003e9\u003c/sup\u003e/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e5.36\u0026nbsp;\u0026plusmn; 1.74\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e5.88\u0026nbsp;\u0026plusmn; 2.11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.545\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e-0.266\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2 (Week 12)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eWBC (x10\u003csup\u003e9\u003c/sup\u003e/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e6.41\u0026nbsp;\u0026plusmn; 1.85\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e5.48\u0026nbsp;\u0026plusmn; 2.76\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.392\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.398\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 (Week 18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eWBC (x10\u003csup\u003e9\u003c/sup\u003e/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e6.93\u0026nbsp;\u0026plusmn; 1.88\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e5.70\u0026nbsp;\u0026plusmn;\u0026nbsp;1.15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.109\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.788\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4 (Week 24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eWBC (x10\u003csup\u003e9\u003c/sup\u003e/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e6.88\u0026nbsp;\u0026plusmn; 2.43\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e6.41\u0026nbsp;\u0026plusmn; 2.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.686\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.196\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 (Baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eTP (g/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e71.80 \u0026plusmn; 4.59\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e70.42\u0026nbsp;\u0026plusmn; 6.45\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.576\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.247\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (Week 6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eTP (g/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e70.88\u0026nbsp;\u0026plusmn; 4.45\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e70.33\u0026nbsp;\u0026plusmn; 5.29\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.824\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.111\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2 (Week 12)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eTP (g/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e74.13\u0026nbsp;\u0026plusmn; 6.03\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e69.22\u0026nbsp;\u0026plusmn; 4.71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.080\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.906\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 (Week 18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eTP (g/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e74.88\u0026nbsp;\u0026plusmn; 6.81\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e67.78\u0026nbsp;\u0026plusmn; 5.36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.030 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1.158\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4 (Week 24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eTP (g/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e71.56\u0026nbsp;\u0026plusmn; 6.33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e68.88\u0026nbsp;\u0026plusmn; 4.61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.340\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.484\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0 (Baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eCr (\u0026micro;mol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e24.67 \u0026plusmn; 9.36\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e24.00\u0026nbsp;\u0026plusmn; 3.87\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.793\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.093\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1 (Week 6)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eCr (\u0026micro;mol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e28.80\u0026nbsp;\u0026plusmn; 7.73\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e30.50\u0026nbsp;\u0026plusmn; 7.45\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.606\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e-0.224\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2 (Week 12)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eCr (\u0026micro;mol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e26.78\u0026nbsp;\u0026plusmn; 6.91\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e28.00\u0026nbsp;\u0026plusmn; 4.77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.636\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e-0.206\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3 (Week 18)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eCr (\u0026micro;mol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e27.90\u0026nbsp;\u0026plusmn; 8.25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e29.33\u0026nbsp;\u0026plusmn; 6.06\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.675\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e-0.198\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4 (Week 24)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003eCr (\u0026micro;mol/L)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e31.50\u0026nbsp;\u0026plusmn; 5.96\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e31.00\u0026nbsp;\u0026plusmn;9.37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.946\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 103px;\"\u003e\n \u003cp\u003e0.034\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 602px;\"\u003e\n \u003cp\u003e* The statistically significant difference between the two means is based on the two-sided Student\u0026rsquo;s t-test with \u003cem\u003ep\u0026nbsp;\u003c/em\u003e\u0026le; 0.05\u0026nbsp;(multiplicity adjusted with false discovery rate). RBAC = rice bran arabinoxylan compound.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 6. Pairwise comparisons of the correlation among global quality of life score (QL2), interferon-gamma (IFN-\u0026gamma;), interleukin-1RA (IL-1RA), interleukin-12p40 (IL-12p40), white blood cell count (WBC), creatinine (Cr) and total protein (TP).\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"595\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePearson\u0026rsquo;s\u003c/strong\u003e \u003cstrong\u003e\u003cem\u003er\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eQL2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIFN-\u003c/strong\u003e\u003cstrong\u003e\u0026gamma;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIL-1RA\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIL-12p40\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWBC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAST\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 53px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTP\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eQL2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 53px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIFN-\u003c/strong\u003e\u003cstrong\u003e\u0026gamma;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e0.168\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 53px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIL-1RA\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.245 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.738 ***\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 53px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIL-12p40\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.246 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.804 ****\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.907 ****\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 53px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eWBC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e0.087\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.211 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.205 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.200 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 53px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAST\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e-0.054\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e-0.240 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e-0.111\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e-0.270 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;0.029\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 53px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTP\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.310 **\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 82px;\"\u003e\n \u003cp\u003e0.051\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e-0.008\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e0.102\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.407 ***\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 63px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e-0.258 *\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 53px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"8\" valign=\"top\" style=\"width: 595px;\"\u003e\n \u003cp\u003ePearson correlation coefficient (\u003cem\u003er\u003c/em\u003e): * weak, ** moderate, *** strong, **** very strong.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 7. Comparisons of the adverse events reported between RBAC and placebo groups.\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"539\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 265px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRBAC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePlacebo\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 265px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNumber of Participants (N)\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 265px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNumber of AEs reported\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e28 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e78 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 265px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean AE per patient\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e2.33\u0026nbsp;\u0026plusmn; 3.22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e4.59\u0026nbsp;\u0026plusmn; 2.87\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.066\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eCTCAE Grade\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e1 \u0026ndash; Mild\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e21 (75.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e62 (79.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.365\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e2 \u0026ndash; Moderate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e6 (21.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e9 (11.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e3 \u0026ndash; Severe\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e4 \u0026ndash; Life-threatening\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e1 (1.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e5 \u0026ndash; Death\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (3.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e1 (1.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrial\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e1 \u0026ndash; Not related\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e15 (53.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e55 (70.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e = 0.191\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eRelationship\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e2 \u0026ndash; Unlikely\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e12 (42.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e21 (26.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e3 \u0026ndash; Possible\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (3.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e2 (2.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e4 \u0026ndash; Probable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e5 \u0026ndash; Definite\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eMost Common\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eFatigue\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e4 (14.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e10 (12.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;= 0.006 **\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eEvents\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eDiarrhoea\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e2 (7.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e4 (5.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eNausea\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e2 (7.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e4 (5.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eOral thrush\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e6 (7.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eRash\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e6 (7.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eConstipation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (3.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e4 (5.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eCough\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e2 (7.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e3 (3.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003ePeripheral neuropathy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (3.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e3 (3.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003ePain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (3.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e2 (2.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eShortness of breath\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e1 (3.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e2 (2.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003eOther isolated events\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e14 (50.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e34 (43.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 85px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 539px;\"\u003e\n \u003cp\u003eNote: Continuous variable is presented in mean\u0026nbsp;\u0026plusmn; standard deviation, and the hypothesis testing of two means is based on the two-sided Student\u0026rsquo;s t-test. Significant testing of categorical variables is computed with Fisher\u0026rsquo;s exact test.\u0026nbsp;AEs = Adverse events;\u0026nbsp;CTCAE =\u0026nbsp;Common Terminology Criteria for Adverse Events; RBAC = rice bran arabinoxylan compound.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Biobran, Biological response modifier, Natural compound, Polysaccharide, Immunomodulator, Immunotherapy, Chemotherapy, Symptom management, Supportive care, Patient-reported outcome measures","lastPublishedDoi":"10.21203/rs.3.rs-5837950/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5837950/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e The effects of a plant-based immunomodulator, rice bran arabinoxylan compound (RBAC), on the quality of life (QoL) of cancer patients during active treatment are unclear.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThe RBAC-QoL study was a randomised, placebo-controlled, double-blind feasibility study to address the role of RBAC in cancer patients receiving systemic therapies. The primary outcome measure was patient-reported functional, symptom, and global QoL scores. Secondary and exploratory outcome measures included nutritional indices and cytokine changes. Adult patients (\u003cem\u003en\u003c/em\u003e = 29) with solid organ tumours (≥ stage II) undergoing systemic treatment were recruited from outpatient centres in New South Wales, Australia. Group allocation was assigned through stratified randomisation (RBAC = 12, placebo = 17). Interventions were either RBAC or matched placebo at 3g/day for 24 weeks. The participants, oncologists, and data collectors were blinded. Data were collected from five study visits, six weeks apart. An intention-to-treat analysis was performed using repeated measure ANOVA with pairwise comparisons where statistical significance was observed. Data sets not conforming to normality were tested with nonparametric ANOVA-type statistics.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eThe global QoL scores differed significantly between groups with a large effect size (\u003cem\u003ep\u003c/em\u003e = 0.031, eta\u003csup\u003e2\u003c/sup\u003e[g] = 0.147). Pairwise comparisons found significant differences favouring the RBAC group at week 6 (\u003cem\u003ep\u003c/em\u003e = 0.017, Cohen’s \u003cem\u003ed\u003c/em\u003e = 1.119) and week 24 (\u003cem\u003ep\u003c/em\u003e = 0.041, \u003cem\u003ed\u003c/em\u003e = 0.970). Compared to the placebo group, the RBAC group showed significantly better role (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.001) and social (\u003cem\u003ep\u003c/em\u003e = 0.037) functioning, while the cognitive functioning score difference was trending higher (\u003cem\u003ep\u003c/em\u003e = 0.055). Regarding cancer symptoms, the placebo group reported significantly worse scores (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05) in fatigue, pain, dyspnoea, and appetite loss compared to the RBAC group. Significant elevations (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05) of cytokine interferon-γ, interleukin 1RA and 12p40, as well as total protein, were also detected in the RBAC group compared to placebo over time. These serum markers correlated positively with the global QoL scores, indicating potential interactions of immune activity, nutritional status, and QoL. No intervention-related adverse events were reported in both groups.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eRBAC improves QoL beyond placebo during systemic cancer treatment, potentially through the immuno-nutritional pathway.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e Prospective registration on the Australian New Zealand Clinical Trials Registry (ANZCTR Reg No: ACTRN12619000562178p, 10/04/2019).\u003c/p\u003e","manuscriptTitle":"Effects of Rice Bran Arabinoxylan Compound on Quality of Life of Cancer Patients During Active Treatment: A Randomised Placebo-controlled Pilot Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-24 10:42:00","doi":"10.21203/rs.3.rs-5837950/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-01-12T04:07:23+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-01-11T13:17:26+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"206693456192025485621666018123261133808","date":"2025-12-19T23:26:56+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"20433664574210450359875688497201562951","date":"2025-09-07T14:50:32+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-18T07:27:17+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"53933660377780958750067398530975628105","date":"2025-07-24T05:42:44+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"7013497803022088944924851725928073791","date":"2025-03-10T04:30:35+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-03-07T14:54:36+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-07T14:40:35+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-01-22T14:46:55+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-01-22T09:15:41+00:00","index":"","fulltext":""},{"type":"submitted","content":"Scientific Reports","date":"2025-01-16T02:10:23+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"b041f823-4ebc-45ef-b494-ada8c5b24da7","owner":[],"postedDate":"March 24th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":45879417,"name":"Biological sciences/Immunology/Translational immunology"},{"id":45879418,"name":"Health sciences/Health care/Quality of life"}],"tags":[],"updatedAt":"2026-03-09T16:11:18+00:00","versionOfRecord":{"articleIdentity":"rs-5837950","link":"https://doi.org/10.1038/s41598-026-41554-8","journal":{"identity":"scientific-reports","isVorOnly":false,"title":"Scientific Reports"},"publishedOn":"2026-03-02 15:57:51","publishedOnDateReadable":"March 2nd, 2026"},"versionCreatedAt":"2025-03-24 10:42:00","video":"","vorDoi":"10.1038/s41598-026-41554-8","vorDoiUrl":"https://doi.org/10.1038/s41598-026-41554-8","workflowStages":[]},"version":"v1","identity":"rs-5837950","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5837950","identity":"rs-5837950","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}