Scalp Cooling in Preventing Chemotherapy-Induced Alopecia for Early Breast Cancer Patients: Long-Term Outcomes of Real- Life Data

Scalp Cooling in Preventing Chemotherapy-Induced Alopecia for Early Breast Cancer Patients: Long-Term Outcomes of Real- Life Data | 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 Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Scalp Cooling in Preventing Chemotherapy-Induced Alopecia for Early Breast Cancer Patients: Long-Term Outcomes of Real- Life Data Mariangela Pasqualoni, Laura Orlando, Dario Loparco, Annamaria Quaranta, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4830396/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose Chemotherapy-induced alopecia (CIA) negatively impacts quality of life of breast cancer patients. The present observational study was designed to confirm the efficacy and safety of scalp-cooling system to prevent CIA in early breast cancer (BC) patients undergoing (neo)adjuvant chemotherapy. Methods We prospectively evaluated all early BC patients undergoing scalp cooling during (neo)adjuvant chemotherapy in our Institution. Primary endpoint was to assess the success of scalp cooling system (hair loss ≤ 50%). Results We included 252 early breast cancer patients treated from May 2016 to July 2023; median age was 49 years, 46% had stage II disease. Most of them received adjuvant chemotherapy (77.4%) and anthracycline-based regimens (78.2%). Hair loss ≤ 50% was observed in 72% of overall patients: in all patients treated with paclitaxel weekly-based chemotherapy, and in 63% and 75% of pts treated with anthracycline and docetaxel-cyclophosphamide regimens respectively (anthracycline-based versus anthracycline-free regimens, p ≤ 0.05). Hair thickness, straightening, permanent hair and BMI were factors linked to the risk of hair loss (p ≤ 0.05). Sixty-nine percent of patients had almost one adverse event, coldness the most frequent (62%); 13% of patients early discontinued the use of the scalp cooling system. With a median months of follow-up of 35 months, no scalp metastasis was reported. Conclusion These results support the use of scalp-cooling in preventing CIA for early breast cancer patients receiving (neo)adjuvant chemotherapy especially if they underwent anthracycline-free regimens, reducing the negative psychological impact of oncological treatments on their lives. scalp-cooling breast cancer chemotherapy-induced alopecia quality of life DigniCap® Figures Figure 1 INTRODUCTION Breast cancer (BC) is the most diagnosed cancer in women worldwide excluding non-melanoma of the skin [ 1 ]. About 90% of BC are diagnosed at early stages and surgery, systemic therapies and radiotherapy led to a 5-years survival of more than 80% according to the stage and other risk factors for relapse [ 2 ]. Despite the options of new drugs in the treatment of early breast cancer, chemotherapy with anthracyclines and/or taxanes is usually proposed to patients in adjuvant or neoadjuvant setting, to reduce the risk of relapse, to increase the possibility of a conservative surgery and to study the aggressiveness of the neoplasm based on the pathological response [ 3 ]. An important aim for physicians involved in breast cancer is reducing the burden of adverse events related to cancer treatment. Among them, one of the most shocking for the majority of breast cancer patients is chemotherapy-induced alopecia (CIA) for its impact on body image, sexuality and self-esteem. Hence, up to 8% of all cancer patients decide to refuse chemotherapy to avoid hair loss [ 4 ]. Hair loss intensity is related to drug category and the number of administered drugs. Poly-chemotherapy is associated with higher incidences compared to monotherapy. Epirubicin/Adriamiycin and cyclophosphamide (EC/AC), weekly paclitaxel (TXL) alone or in combination with carboplatin are associated with a risk of alopecia of more than 90%. It usually occurs after the first cycle starting around the fourteenth day for the EC/AC regimen and during the first month of therapy for weekly regimens [ 5 , 6 ]. Immunomodulatory agents targeting cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death protein-1 (PD-1), and programmed death-ligand-1 (PD-L1) or anti human epidermal growth factor receptor 2 (HER2) such as trastuzumab and pertuzumab alone are not associated with increased risk or hair loss [ 7 ]. The most important factor influencing the shedding pattern is the mitotic activity of the hair follicle [ 8 ]. Up to 90% of scalp hairs are normally in anagen phase with the highest mitotic rate and so great vulnerability to drugs. Nowadays, CIA pathobiology is still an unresolved question. Chemotherapy damages the metabolically active, fast-growing scalp hair follicles (HFs) causing massive apoptosis in the maximally proliferating hair matrix, especially of the p53-dependent matrix keratinocyte [ 9 ]. Age, comorbidities, the presence of any previous type of alopecia (more frequently androgenetic alopecia) and nutritional and hormonal status are considered risk factors for CIA [ 10 ]. Several approaches have been tested for preventing or treating CIA: scalp hypothermia, topical epinephrine or norepinephrine to decrease the amount of drug delivered to the hair bulb as well as pharmacologic and biological interventions able to block the effects of the chemotherapy on the follicle and promote hair growth (topical bimatoprost, topical minoxidil, and topical calcitriol) [ 11 ]. A recent meta-analysis showed that scalp cooling is the only approach able to induce a significant reduced risk of CIA [ 12 ]. In the last few years, a lot of data has been published about the efficacy and safety of the scalp cooling system with the DigniCap® device. In 2019 we published a prospective observational study about our experience with the use of the DigniCap® scalp cooling system for preventing CIA in 127 early breast cancer patients undergoing (neo)adjuvant chemotherapy at our Institute “Perrino Hospital” of Brindisi and we found an overall success rate of 71.7% [ 13 ]. The present analysis aims to evaluate the long-term outcomes of the scalp cooling system in these patients and to analyze its effectiveness and safety in a larger number of patients. MATERIALS AND METHODS 2.1 Study Design and Participants In our Oncology Unit, scalp cooling (SC) system with DigniCap® was offered to all early breast cancer patients older than 18 years subjected to neoadjuvant or adjuvant chemotherapy since May 2016 and all the data referred to SC were prospectively collected. Controindication of the DigniCap® SC system were cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy and patient refusal. The local Ethics Committee approved the study and we acquired a written informed consent for every patient. 2.2. Procedures In our Institution two DigniCap® devices are available to allow the treatment of four patients simultaneously without additional costs for any patient. Data about the patients' distress, adverse events and scalp cooling outcomes were collected at each cycle by a psycho-oncologist. Researchers anonymized all these informations by putting them in a database, adding information about patient's characteristics (age, menopausal status, BMI.), tumor biology (stage, grading, phenotype) and hair features. Alopecia was evaluated according to Deans’s scale for hair loss: grade 1/excellent ( 75% hair loss). Success was defined as hair loss 50% hair loss (Grade 3–4) [ 14 ]. 2.3 Objectives Our primary objective was to assess efficacy in preventing CIA, tolerability and long-term outcomes of the scalp cooling system (DigniCap® devices) in early breast cancer patients treated with systemic chemotherapy. Secondary end-point was to test the correlation among some patient’s features and DigniCap® devices outcome. 2.3 Statistical Analysis Patient demographics and clinical characteristics were reported using descriptive statistics: medians with interquartile range (IQR) were used for continuous variables and absolute counts with relative frequencies for categorical variables. The association between variables was evaluated with Fisher’s exact test and the strength of the association with Cramer’s V. A logistic regression model was implemented with an univariable and a multivariable analysis; odds ratio (OR), 95% confidence intervals (CI) and p-values were reported. The level of significance was set at p < 0.05. Jamovi (version 2.4.8) was used for statistical analyses. RESULTS Table 1 Clinicopathologic patients’ characteristics at the time of CT starting N (%) of Patients Age median (range) 49 (42-56) Menopausal Status Premenopausal 143 (57%) Postmenopausal 108 (43%) Race Caucasian 193 (76.6%) Mediterranean 55 (21.8%) African 3 (1.2%) Asian 1 (0.4%) Hystotype Ductal 233 (92%) Lobular 9 (4%) Other 10 (4%) Phenotype ER and/or PgR pos 169 (67%) ER and/or PgR neg 83 (33%) HER2 pos. 93 (37%) HER2 neg. 159 (63%) Ki67 status Ki67 <20% 70 (28%) Ki67 ≥ 20% 182 (72%) Histological Grade 1 4 (2%) 2 97 (38%) 3 148 (59%) UNK 3 (1%) cT/pT 1 129 (51%) 2 94 (37%) 3 20 (8%) 4 7 (3%) UNK 2 (1%) cN/pN 0 113 (45%) 1 93 (37%) 2 23 (9%) 3 19 (8%) UNK 4 (2%) Disease Stage (AJCC) I 79 (31%) II 117 (46%) III 56 (22%) Body Mass Index Healthy Weight 132 (52%) Under Weight 10 (4%) Over Weight 77 (31%) Obesity 33 (13%) Smokers Yes 26 (10.3%) No 198 (78.6%) UNK 28 (11.1%) Chemotherapy regimens EC→TXL weekly 75 (29.8%) EC 72 (28.6%) TXL + TRAST. Weekly 46 (18.3%) EC→TXL+TRAST.weekly 35 (13.9%) EC→TXL + CBDCA weekly 5 (2.0%) EC→TXL+TRAST.+PERT. weekly 5 (2.0%) (TXL+CBDCA weekly→EC )+PEMBRO. 5 (2.0%) TC 5 (2.0%) EC→CMF 5 (2.0%) CBDCA+TXL+TRAST. Weekly 1 (0.4%) EC→CMF+TRAST 1 (0.4%) Anthracycline based regimens Yes 197 (78.2%) No 55 (21.8%) Chemotherapy setting Adjuvant 195 (77.4%) Neoadjuvant 57 (22.6%) Abbreviations: AJCC, American Joint Committee on Cancer; ER, estrogen receptor; PgR, progesterone receptor; pos., positive; HER2, human epidermal growth factor receptor 2; TXL, paclitaxel; TRAST, trastuzumab; CBDCA, carboplatin; EC, epirubicin – cyclophosphamide; TC, docetaxel - cyclophosphamide; PEMBRO., pembrolizumab; CMF, cyclophosphamide-methotrexate-5-fluorouracil; PERT., pertuzumab; UNK, unknown. One hundred and seventeen patients had II stages of the disease according to the AJCC system classification (43%), 31% and 22% of patients had stage I and III respectively. Patients received different chemotherapy regimens, mainly anthracyclines containing regimens (78.2%) and in the adjuvant setting (77.4%) 4.2 Scalp Cooling Efficacy The scalp cooling device success rate (Dean’s alopecia scale score 0-2 equal to a hair loss ≤ 50%) was 72% for all evaluable patients at the end of chemotherapy treatment (248 out of 252). Differences in response to SC device according to the chemotherapy regimens were listed in Table 2. Table 2 Features related to chemotherapy regimens used and hair loss degree evaluated by medical staff at the end of all cycles of chemotherapy Chemotherapy regimens Treatment completed N. (%) of Patients Hair loss ≤ 50% N. (%) of Patients Hair loss >50% N. (%) of Patients Treatment prematurely stopped (%) Reason (n) EC→TXL weekly 59 (81.9%) 39 (66.1%) 20 (33.9%) 13 (18.1%) Alopecia (7), coldness (3), others (3) EC 64 (88.9%) 41 (64.1%) 23 (35.9%) 8 (11.1%) Alopecia (2), pain (2), others (2) TXL + TRAST. Weekly 46 (100%) 46 (100%) EC→TXL+TRAST.weekly 27 (80%) 18 (66.7%) 9 (33.3%) 8 (22.9%) Alopecia (5), coldness (1), other (1) EC→TXL + CBDCA weekly 5 (100%) 2 (40%) 3 (60%) EC→TXL+TRAST.+PERT. weekly 3 (60%) 3 (100%) 2 (40%) Others (2) (TXL+CBDCA weekly→EC )+PEMBRO. 4 (100%) 4 (100%) TC 5 (80%) 3 (75%) 1 (25%) 1 (20%) Alopecia EC→CMF 2 (100%) 1 (50%) CBDCA+TXL+TRAST. Weekly 1 (100%) 1 (100%) EC→CMF+TRAST 1 (100%) 1 (100%) Abbreviation: TXL, paclitaxel; TRAST, trastuzumab; CBDCA, carboplatin; EC, epirubicin – cyclophosphamide; TC, docetaxel - cyclophosphamide; PEMBRO., pembrolizumab; CMF, cyclophosphamide-methotrexate-5-fluorouracil; PERT., pertuzumab; Efficacy of 100% in preventing hair loss > 50% was observed in all patients undergoing paclitaxel weekly-based chemotherapy. Moreover, among 46 patients treated with weekly paclitaxel-based chemotherapy (forty-five received paclitaxel-trastuzumab and one paclitaxel-carboplatin-trastuzumab regimen) no one has had a hair loss evaluated by Dean's scale more than G1 and the majority (42 out of 46) did not experienced any hair loss (G0 according to Dean's scale). Even if only four patients received chemotherapy with anthracyclines after weekly paclitaxel, all these patients had hair loss ≤ 50% (Figure 1). Table 3 The hair loss degree related to anthracycline based versus anthracycline free regimes Variable Hair loss ≤ 50% N. (%) of Patients Hair loss >50% (%) N. (%) of Patients p-value Anthracycline free chemoterapy 49 (98.0%) 1 (2.0%) <0.001* (Cramer’s V: 0.310) Anthracycline free chemoterapy 108 (65.5%) 57 (34.5%) p-value: Fisher’s exact test; *anthracycline based chemotherapy versus anthracycline free chemotherapy In our series, hair thickness, hair straightening and hair permanent were related to the risk of hair loss; hair structure, previous alopecia, dyed hair and hair density were not significantly related to scalp-cooling failure (Table 4 and Table 5) Table 4. The hair loss degree according to the hair’s patient characteristics at baseline. N (%) of Patients Hair loss ≤ 50% N. of Patients (%) Hair loss > 50% N. of Patients (%) p-Value Hair thickness Fine 76 (30.5%) 59 (77.6%) 17 (22.4%) 0,02* Medium 94 (37.7%) 72 (76.6%) 22 (23.4%) Thick 79 (31.7%) 47 (59.5%) 32 (40.5%) Hair structure Straight 127 (51%) 97 (76.3%) 30 (23.6%) 0,07* Wavy 88 (36%) 61 (69.3%) 27 (30.6%) Curly 32 (13%) 18 (56.2%) 14 (43.7%) Hair density Low 156 (63.1%) 109 (69.9%) 47 (30.1%) 0,64* Medium 88 (35.6%) 64 (72.7%) 24 (27.3%) High 3 (1.2%) 3 (100%) 0 (0.0%) Pevious alopecia Yes 10 (4.1%) 10 (100%) 0 (0.0%) 0,67* No 237 (95.9%) 166 (70.0%) 71 (30.0%) Dyed hair Yes 171 (69%) 121 (70.7%) 51 (29.8%) 0,64* No 76 (31%) 56 (73.6%) 20 (26.3%) Hair straightening Yes 37 (15%) 144 (68.5%) 66 (31.4%) 0,03* No 210 (85%) 32 (86.4%) 5 (13.5%) Hair permanent Yes 8 (3%) 7 (88%) 1 (13%) 0,44* No 239 (97%) 169 (71%) 70 (29%) *p-value: Fischer’s exact test. Table 5. The hair loss degree according to the patient characteristics. Variables Hair loss ≤ 50% N. of Patients (%) Hair loss > 50% N. of Patients (%) p-Value BMI Overweight 61 (80.3%) 15 (19.7%) 0,003* Healthy weight 82 (64.1%) 46 (35.9%) Underweight 5 (50.0%) 5 (50.0%) Obese 29 (87.9) 4 (12.1) Smokers Yes 22 (84.6%) 4 (15.4%) 0,114* No 137 (69.2%) 61 (30.8%) Age Under 50 94 (69.6%) 41 (30.4%) 0,480* Over 50 83 (74.1%) 29 (25.9%) Menopausal status Premenopausal 91 (67.4%) 44 (32.6%) 0,117* Postmenopausal 83 (76.9%) 25 (23.1%) *p-value: Fischer’s exact test. Univariate and multivariate logistic regression analysis of hair loss degree according to the patient and treatment characteristics were reported in Table 6. The multivariate analysis identified the type of chemotherapy regimen, BMI and high hair thickness as independent factors for hair loss. Table 6. Univariate and multivariate analysis Variable Univariate Multivariate OR (95% CI) p-Value OR (95% CI) p-Value Anthracycline based chemotherapy No Ref. 0.002 Ref. Yes 25.1743 (3.387-187.096) 21.447 (2.845-161.676) 0.003* Hair thickness Medium Ref. Ref. Fine -Medium 0,918 (0.402-2.096) 0.838 1.031 (0.419-2.535) 0.946 Thick - Medium 2.490 (1.218-5.091) 0.012 2.577 (1.185-5.601) 0.017* Hair straightening No Ref. Ref. Yes 0.428 (0.157-1.165) 0.097 0.391 (0.132-1.162) 0.091 Hair permanent No Ref. Yes 0.385 (0.0463-3.202) 0.377 BMI Healthy Weight Ref. Ref. Overweight-Healthy weight 0.438 (0.2242-0.857) 0,016 0.549 (0.247-1.219) 0.141 Under-weight-Healty-weight 1.783 (0.4902-6.483) 0,380 3.519 (0.724-17.099) 0.119 Obese-Healthy-weight 0.246 (0.0814-0.743) 0,013 0.250 (0.067-0.926) 0.038* *p-value < 0.05 4.3 Adverse Events Sixty-nine percent of all evaluable patients had almost one adverse event, 13% of them early interrupted the use SC system, the majority within the first cycles. The most frequent cause was incoming alopecia in 15 patients (47%). Fear of scalp metastases was the reason of early discontinuation in one patient. Five patients early discontinued due to coldness and two patients due to cervical pain and headache respectively. Table 7 show the frequencies of the adverse events associated with the SC device reported by patients. Coldness was the most frequently adverse event registered in 152 out of 247 (62%) patients, severe in 43%. The second most common adverse event was headache (129/247), mostly mild in gravity (24%). Table 7. Frequencies of SC adverse events and their gravity according to the patient’s description. Adverse Events No (%) Yes (%) Mild (%) Moderate (%) Severe (%) Headache 118 (47.8%) 129 (52.2%) 66 (51.2%) 39 (30.2%) 24 (18.6%) Scalp Pain 138 (55.9%) 109 (44.1%) 54 (49.1%) 37 (33.6%) 19 (17.3%) Neck Pain 147 (59.5%) 100 (40.5%) 49 (49.5%) 35 (35.4%) 15 (15.2%) Coldness 94 (38.1%) 153 (61.9%) 54 (35.8%) 36 (23.8%) 61 (40.4%) Heavy Head 110 (44.5%) 137 (55.5%) 51 (37.2%) 64 (46.7%) 22 (16.1%) 4.4 Follow-up Median follow-up was 35 months (range 12-62) for 248 evaluable patients; fifteen (6%) patients had a relapse of breast cancer. The site of relapse was known in ten patients: one local, six in the liver, two in the brain and one in the bone. At the end of the data cut-off, 11 died for breast cancer relapse (4.4%). No scalp metastasis was reported among the study participants. DISCUSSION Chemotherapy-induced alopecia is one of the most stressful adverse event for breast cancer patients. Our prospective observational analysis confirmed the possibility of avoiding CIA with the use of the scalp cooling system (DigniCap®) in the majority of early breast cancer patients. These data, collected in our center in a larger number of patients, confirmed our previously reported results [13]: overall hair preservation rate was observed in 72% of patients, also in those who received an anthracycline-based chemotherapy regimen (78% of the total population) and only 34.5% of them experienced hair loss > 50%. In line with the literature, we found a statistically significant difference in the efficacy of the scalp cooling system according to the use of anthracyclines (p < 0.001). Moreover, all 46 of patients treated with a weekly paclitaxel-based chemotherapy had a success rate of 100%, with the majority of them (42 out of 46) with hair loss G0 according to the Dean’s scale of alopecia. These results are consistent with two other prospective studies both evaluating the efficacy of the use of the DigniCap® scalp cooling system in preventing CIA in early breast cancer patients. Giarratano et al, showed an overall success rate of 60% which was higher in non-anthracycline (71%) than in anthracycline-based regimens (54%, p<0.001) [15]. Carbognin et al, reported hair preservation in 88% of patients in taxane-based (docetaxel or paclitaxel) chemotherapy group compared to 60.2% in anthracycline and taxane-based chemotherapy group (p < 0.001) with also a 100% success rate in the paclitaxel alone group [16]. In our study the multivariate analysis identified the chemotherapy regimen as an independent risk factor for hair loss, remarking that chemotherapy with anthracycline increased the risk of alopecia when compared to non-anthracycline chemotherapy regimens also with the use of scalp cooling system. Another prospective study conducted in 2021 evaluated 163 early breast cancer patients eligible for adjuvant therapy. This study confirmed that with the use of the DigniCap® scalp cooling system, hair preservation was successful in 57% of patients in the overall series, reaching 81% of success in the patient subgroup treated with a paclitaxel and trastuzumab regimen. Side effects (feeling cold, headache, head heaviness, scalp and cervical pain) were mild to moderate and did not correlate with the rate of hair loss [17]. Several studies have found that some patients' characteristics as nicotine abuse, premenopausal status or some hair’s features like hair density, hair structure and thickness were associated with scalp cooling system outcomes. [16-18]. In our analysis we confirmed the relationship between hair thickness and scalp cooling system efficacy, but we also reported a relationship with hair straightening and hair permanent. Moreover, we found a statistically significance relation between high BMI and hair loss of less than 50%, which was never found before. These data were confirmed by the multivariate analysis. Many reasons can be hypothesized to explain this data. Overweight or obese women with breast cancer often received a reduced dose of cytotoxic drugs, based on ideal body weight [19]. Another reason for this association might be related to the lower relative dose intensity (RDI) of anthracycline and taxane-based chemotherapy due to excess adiposity [20]. Both these possible explanations might explain a lower rate or intensity of CIA, especially if associated with the use of scalp hypothermia, but these associations should be further investigated. In our study, 13% of patients discontinued the use of the device early, mainly for adverse events. This data is in line with results reported in literature where a percentage of discontinuation ranging from 10% to 13% was reported. With a median follow-up of 35 months, only 6% of patients had a relapse of the disease, no one had skin scalp metastases and only two progressed in the central nervous system. One of the most frequent worries of the patients and concerns of physicians about SC system is the hypothetical increased risk of cutaneous scalp relapse due to the lower concentration of the chemotherapy in their vessels. In 2017, a systematic review and meta-analysis of longitudinal studies was undertaken to evaluate the effect of scalp cooling versus no scalp cooling on the risk of scalp metastasis in breast cancer patients treated with chemotherapy. The study showed a very low incidence rate of scalp metastasis in the scalp cooling group versus the no scalp cooling group (0.61% versus 0.41%, P=0.43) suggesting that the use of scalp hypothermia to prevent CIA did not increase the incidence of scalp metastases [21]. Few data are available on the risk of central nervous system metastases and in our series only two patients, both with HER-2 positive disease, experienced CNS metastasis as first recurrence . In conclusion, our data confirmed prospectively the scalp cooling efficacy in a large number of patients enrolled in a single oncological center; efficacy and tolerability of the scalp cooling system are in line with that found in the literature with an overall success rate of 72% and of 100% for patients undergoing a weekly paclitaxel chemotherapy regimen, thus confirming the results of our previous analysis in a larger number of patients without new or long term toxicity or particular concerns with a longer follow-up. However, some limitations need to be highlighted. The present study was observational and didn't collect data about global patients personal experience, quality of life, the contemporary use of an headgear, dermatological analysis of the hair status by a specialist at baseline and at the end of the treatment. Despite these considerations, the use of the scalp cooling device like DigniCap® is an important equipment to offer to early breast cancer patients to improve compliance to treatments, outcome and quality of life. Abbreviations CIA Chemotherapy-induced alopecia BC Breast cancer EC/AC Epirubicin/Adriamiycin and cyclophosphamide WHO World Health Organization HR Hormone Receptors HER2 Human Epidermal Growth Factor Receptor 2 TXL Paclitaxel CTLA-4 T-lymphocyte-associated protein-4 PD-1 Programmed cell Death protein-1 PD-L1 Programmed Death-Ligand-1 HFs Scalp hair follicles SC Scalp Cooling FDA Food and Drug Administration CT Chemotherapy Declarations Funding The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. Competing Interests The authors have no relevant financial or non-financial interests to disclose. Author Contributions All authors contributed to the study's conception and design. Material preparation and data collection were performed by Dario Loparco, Annamaria Quaranta, Paola Schiavone, Chiara Caliolo, Mariangela Pasqualoni and Mariangela Rendini. 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International Journal of Cancer 136, fasc. 5 https://doi.org/10.1002/ijc.29115 Orlando L, Loparco D, Fedele P, Schiavone P, Quaranta A, Caliolo C, Cinefra M et al (2019) ottobre. «Final Results of a Prospective Study of Scalp Cooling in Preventing Chemotherapy-Induced Alopecia». Future Oncology 15, fasc. 29 : 3337–44. https://doi.org/10.2217/fon-2019-0066 Dean JC, Salmon SE, Griffith KS (1979) Prevention of doxorubicin-induced hair loss with scalp hypothermia. N Engl J Med 301:1427 Giarratano T, Frezzini S, Zanocco M, Giorgi CA, Mioranza E, Miglietta F, Griguolo G et al (2020) luglio. «Use of Scalp Cooling Device to Prevent Alopecia for Early Breast Cancer Patients Receiving Chemotherapy: A Prospective Study». The Breast Journal 26, fasc. 7 : 1296–1301. https://doi.org/10.1111/tbj.13711 Carbognin L, Accetta C, Giorgio DD, Fuso P, Muratore M, Tiberi G, Pavese F et al «Prospective Study Investigating the Efficacy and Safety of a Scalp Cooling Device for the Prevention of Alopecia in Women Undergoing (Neo)Adjuvant Chemotherapy for Breast Cancer». Current Oncology 29, fasc. 10 (30 settembre 2022): 7218–28. https://doi.org/10.3390/curroncol29100569 Pedersini R, Fornaro C, Mauro Pdi, Bianchi S, Vassalli L, Amoroso V, Gelmi M et al (2021) giugno. «Efficacy of the DigniCap System in Preventing Chemotherapy-induced Alopecia in Breast Cancer Patients Is Not Related to Patient Characteristics or Side Effects of the Device». International Journal of Nursing Practice 27, fasc. 3 : e12888. https://doi.org/10.1111/ijn.12888 Schaffrin-Nabe D, Schmitz I, Josten-Nabe A, von Hehn U, Voigtmann R (2015) The Influence of Various Parameters on the Success of Sensor-Controlled Scalp Cooling in Preventing Chemotherapy-Induced Alopecia. Oncol Res Treat 38(10):489–495. 10.1159/000440636 Epub 2015 Sep 27. PMID: 26451590 Griggs JJ, Melony ES, Sorbero H Lyman. «Undertreatment of Obese Women Receiving Breast Cancer Chemotherapy». Archives of Internal Medicine 165, fasc. 11 (13 giugno 2005): 1267. https://doi.org/10.1001/archinte.165.11.1267 Cespedes Feliciano EM, Wendy Y, Chen V, Lee KB, Albers CM, Prado S, Alexeeff J, Xiao, Shlomit S Shachar, e Bette J. Caan. «Body Composition, Adherence to Anthracycline and Taxane-Based Chemotherapy, and Survival After Nonmetastatic Breast Cancer». JAMA Oncology 6, fasc. 2 (1 febbraio 2020): 264. https://doi.org/10.1001/jamaoncol.2019.4668 Rugo HS, Susan A, Melin eJ, Voigt (2017) «Scalp Cooling with Adjuvant/Neoadjuvant Chemotherapy for Breast Cancer and the Risk of Scalp Metastases: Systematic Review and Meta-Analysis». Breast Cancer Research and Treatment 163, fasc. 2giugno : 199–205. https://doi.org/10.1007/s10549-017-4185-9 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted 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. 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Also discoverable on Platform About Our Team In Review Editorial Policies 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-4830396","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":337309273,"identity":"1ee1b233-ccc0-484f-b9e5-291497ef2924","order_by":0,"name":"Mariangela Pasqualoni","email":"data:image/png;base64,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","orcid":"","institution":"Università Cattolica del Sacro Cuore","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Mariangela","middleName":"","lastName":"Pasqualoni","suffix":""},{"id":337309274,"identity":"a1bb4eef-fe33-4986-811a-de2ad5d94ece","order_by":1,"name":"Laura Orlando","email":"","orcid":"","institution":"Antonio Perrino Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Laura","middleName":"","lastName":"Orlando","suffix":""},{"id":337309275,"identity":"a6047d3d-c55e-4a7c-a4cb-afe8fdff2b63","order_by":2,"name":"Dario Loparco","email":"","orcid":"","institution":"Antonio Perrino Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Dario","middleName":"","lastName":"Loparco","suffix":""},{"id":337309276,"identity":"d9234fa5-479a-431d-989b-d2e8e941c11f","order_by":3,"name":"Annamaria Quaranta","email":"","orcid":"","institution":"Antonio Perrino Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Annamaria","middleName":"","lastName":"Quaranta","suffix":""},{"id":337309277,"identity":"d88b4c34-3458-4611-97cc-f6d9ba1d5abb","order_by":4,"name":"Chiara Caliolo","email":"","orcid":"","institution":"Antonio Perrino Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Chiara","middleName":"","lastName":"Caliolo","suffix":""},{"id":337309278,"identity":"77835374-4473-4b13-a97c-8cd479d590bc","order_by":5,"name":"Paola Schiavone","email":"","orcid":"","institution":"Antonio Perrino Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Paola","middleName":"","lastName":"Schiavone","suffix":""},{"id":337309279,"identity":"2181b52d-6f37-4fea-aba6-4f2298393e4e","order_by":6,"name":"Luca Mastrantoni","email":"","orcid":"","institution":"Università Cattolica del Sacro Cuore","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Luca","middleName":"","lastName":"Mastrantoni","suffix":""},{"id":337309280,"identity":"9c4304c7-58cc-4b99-86da-207d433a23f8","order_by":7,"name":"Mariangela Rendini","email":"","orcid":"","institution":"Antonio Perrino Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Mariangela","middleName":"","lastName":"Rendini","suffix":""},{"id":337309281,"identity":"23395a82-f805-43e7-9673-0f4aafd96b4b","order_by":8,"name":"Giampaolo Tortora","email":"","orcid":"","institution":"Università Cattolica del Sacro Cuore","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Giampaolo","middleName":"","lastName":"Tortora","suffix":""},{"id":337309282,"identity":"cc0a4731-a381-46f8-b650-20dbd5281a54","order_by":9,"name":"Saverio Cinieri","email":"","orcid":"","institution":"Antonio Perrino Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Saverio","middleName":"","lastName":"Cinieri","suffix":""}],"badges":[],"createdAt":"2024-07-30 17:07:03","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4830396/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4830396/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":63888171,"identity":"4625ba9e-cfc9-4216-8aab-d00e483b802d","added_by":"auto","created_at":"2024-09-03 11:43:00","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":161158,"visible":true,"origin":"","legend":"\u003cp\u003eSuccess rate according to the different chemotherapy regimens. A. Success based on hair loss ≤ 50% (Dean’s scale grade 0 to 2). B. Success based\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4830396/v1/36ad5b747873ba0ac6d0e0b3.jpg"},{"id":72634605,"identity":"d7ee4681-b019-4145-88c8-268f4b254b1e","added_by":"auto","created_at":"2024-12-30 14:54:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1209151,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4830396/v1/4129bfd4-ec5e-4068-ace7-0b76b53cd371.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eScalp Cooling in Preventing Chemotherapy-Induced Alopecia for Early Breast Cancer Patients: Long-Term Outcomes of Real- Life Data\u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eBreast cancer (BC) is the most diagnosed cancer in women worldwide excluding non-melanoma of the skin [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. About 90% of BC are diagnosed at early stages and surgery, systemic therapies and radiotherapy led to a 5-years survival of more than 80% according to the stage and other risk factors for relapse [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Despite the options of new drugs in the treatment of early breast cancer, chemotherapy with anthracyclines and/or taxanes is usually proposed to patients in adjuvant or neoadjuvant setting, to reduce the risk of relapse, to increase the possibility of a conservative surgery and to study the aggressiveness of the neoplasm based on the pathological response [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAn important aim for physicians involved in breast cancer is reducing the burden of adverse events related to cancer treatment. Among them, one of the most shocking for the majority of breast cancer patients is chemotherapy-induced alopecia (CIA) for its impact on body image, sexuality and self-esteem. Hence, up to 8% of all cancer patients decide to refuse chemotherapy to avoid hair loss [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eHair loss intensity is related to drug category and the number of administered drugs. Poly-chemotherapy is associated with higher incidences compared to monotherapy.\u003c/p\u003e \u003cp\u003eEpirubicin/Adriamiycin and cyclophosphamide (EC/AC), weekly paclitaxel (TXL) alone or in combination with carboplatin are associated with a risk of alopecia of more than 90%. It usually occurs after the first cycle starting around the fourteenth day for the EC/AC regimen and during the first month of therapy for weekly regimens [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Immunomodulatory agents targeting cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death protein-1 (PD-1), and programmed death-ligand-1 (PD-L1) or anti human epidermal growth factor receptor 2 (HER2) such as trastuzumab and pertuzumab alone are not associated with increased risk or hair loss [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe most important factor influencing the shedding pattern is the mitotic activity of the hair follicle [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Up to 90% of scalp hairs are normally in anagen phase with the highest mitotic rate and so great vulnerability to drugs.\u003c/p\u003e \u003cp\u003eNowadays, CIA pathobiology is still an unresolved question. Chemotherapy damages the metabolically active, fast-growing scalp hair follicles (HFs) causing massive apoptosis in the maximally proliferating hair matrix, especially of the p53-dependent matrix keratinocyte [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAge, comorbidities, the presence of any previous type of alopecia (more frequently androgenetic alopecia) and nutritional and hormonal status are considered risk factors for CIA [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSeveral approaches have been tested for preventing or treating CIA: scalp hypothermia, topical epinephrine or norepinephrine to decrease the amount of drug delivered to the hair bulb as well as pharmacologic and biological interventions able to block the effects of the chemotherapy on the follicle and promote hair growth (topical bimatoprost, topical minoxidil, and topical calcitriol) [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. A recent meta-analysis showed that scalp cooling is the only approach able to induce a significant reduced risk of CIA [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. In the last few years, a lot of data has been published about the efficacy and safety of the scalp cooling system with the DigniCap\u0026reg; device.\u003c/p\u003e \u003cp\u003eIn 2019 we published a prospective observational study about our experience with the use of the DigniCap\u0026reg; scalp cooling system for preventing CIA in 127 early breast cancer patients undergoing (neo)adjuvant chemotherapy at our Institute \u0026ldquo;Perrino Hospital\u0026rdquo; of Brindisi and we found an overall success rate of 71.7% [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe present analysis aims to evaluate the long-term outcomes of the scalp cooling system in these patients and to analyze its effectiveness and safety in a larger number of patients.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Study Design and Participants\u003c/h2\u003e \u003cp\u003eIn our Oncology Unit, scalp cooling (SC) system with DigniCap\u0026reg; was offered to all early breast cancer patients older than 18 years subjected to neoadjuvant or adjuvant chemotherapy since May 2016 and all the data referred to SC were prospectively collected. Controindication of the DigniCap\u0026reg; SC system were cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy and patient refusal. The local Ethics Committee approved the study and we acquired a written informed consent for every patient.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2. Procedures\u003c/h2\u003e \u003cp\u003eIn our Institution two DigniCap\u0026reg; devices are available to allow the treatment of four patients simultaneously without additional costs for any patient.\u003c/p\u003e \u003cp\u003eData about the patients' distress, adverse events and scalp cooling outcomes were collected at each cycle by a psycho-oncologist. Researchers anonymized all these informations by putting them in a database, adding information about patient's characteristics (age, menopausal status, BMI.), tumor biology (stage, grading, phenotype) and hair features. Alopecia was evaluated according to Deans\u0026rsquo;s scale for hair loss: grade 1/excellent (\u0026lt;\u0026thinsp;25% hair loss), grade 2/good (25%-50% hair loss), grade 3/moderate (50%-75% hair loss), and grade 4/poor (\u0026gt;\u0026thinsp;75% hair loss). Success was defined as hair loss\u0026thinsp;\u0026lt;\u0026thinsp;50% according to Dean\u0026rsquo;s scale (Grade 0\u0026ndash;2); failure was defined as \u0026gt;\u0026thinsp;50% hair loss (Grade 3\u0026ndash;4) [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Objectives\u003c/h2\u003e \u003cp\u003eOur primary objective was to assess efficacy in preventing CIA, tolerability and long-term outcomes of the scalp cooling system (DigniCap\u0026reg; devices) in early breast cancer patients treated with systemic chemotherapy. Secondary end-point was to test the correlation among some patient\u0026rsquo;s features and DigniCap\u0026reg; devices outcome.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Statistical Analysis\u003c/h2\u003e \u003cp\u003e Patient demographics and clinical characteristics were reported using descriptive statistics: medians with interquartile range (IQR) were used for continuous variables and absolute counts with relative frequencies for categorical variables. The association between variables was evaluated with Fisher\u0026rsquo;s exact test and the strength of the association with Cramer\u0026rsquo;s V. A logistic regression model was implemented with an univariable and a multivariable analysis; odds ratio (OR), 95% confidence intervals (CI) and p-values were reported. The level of significance was set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05. Jamovi (version 2.4.8) was used for statistical analyses.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003eTable 1\u003c/strong\u003e Clinicopathologic patients\u0026rsquo; characteristics at the time of CT starting\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"382\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eN (%) of Patients\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge median (range)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e49 (42-56)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMenopausal Status\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003ePremenopausal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e143 (57%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003ePostmenopausal\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e108 (43%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eRace\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eCaucasian\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e193 (76.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eMediterranean\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e55 (21.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eAfrican\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e3 (1.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eAsian\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e1 (0.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHystotype\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eDuctal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e233 (92%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eLobular\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e9 (4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e10 (4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePhenotype\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eER and/or PgR pos\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e169 (67%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eER and/or PgR neg\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e83 (33%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eHER2 pos.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e93 (37%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eHER2 neg.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e159 (63%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eKi67 status\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eKi67 \u0026lt;20%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e70 (28%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eKi67 \u0026ge; 20%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e182 (72%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHistological Grade\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e4 (2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e97 (38%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e148 (59%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eUNK\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e3 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ecT/pT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e129 (51%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e94 (37%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e20 (8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e7 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eUNK\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e2 (1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ecN/pN\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e113 (45%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e93 (37%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e23 (9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e19 (8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eUNK\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e4 (2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDisease Stage (AJCC)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e79 (31%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e117 (46%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e56 (22%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eBody Mass Index\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eHealthy Weight\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e132 (52%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eUnder Weight\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e10 (4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eOver Weight\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e77 \u0026nbsp; \u0026nbsp; (31%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eObesity\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e33 (13%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSmokers\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;26 (10.3%) \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e198 (78.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eUNK\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e28 (11.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eChemotherapy regimens\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eEC\u0026rarr;TXL weekly\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e75 (29.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eEC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e72 (28.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eTXL + TRAST. Weekly\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e46 (18.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eEC\u0026rarr;TXL+TRAST.weekly\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e35 (13.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eEC\u0026rarr;TXL + CBDCA weekly\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e5 (2.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eEC\u0026rarr;TXL+TRAST.+PERT. weekly\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e5 (2.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003e(TXL+CBDCA weekly\u0026rarr;EC )+PEMBRO.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e5 (2.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eTC\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e5 (2.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eEC\u0026rarr;CMF\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e5 (2.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eCBDCA+TXL+TRAST. Weekly\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e1 (0.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eEC\u0026rarr;CMF+TRAST\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e1 (0.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnthracycline based regimens\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e197 (78.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e55 (21.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eChemotherapy setting\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eAdjuvant\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e195 (77.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"54.59317585301837%\" valign=\"top\"\u003e\n \u003cp\u003eNeoadjuvant\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"45.40682414698163%\" valign=\"top\"\u003e\n \u003cp\u003e57 (22.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAbbreviations: AJCC, American Joint Committee on Cancer; ER, estrogen receptor; PgR, progesterone receptor; pos., positive; HER2, human epidermal growth factor receptor 2; TXL, paclitaxel; TRAST, trastuzumab; CBDCA, carboplatin; EC, epirubicin \u0026ndash; cyclophosphamide; TC, docetaxel - \u0026nbsp;cyclophosphamide; PEMBRO., pembrolizumab; CMF, \u0026nbsp; cyclophosphamide-methotrexate-5-fluorouracil; PERT., pertuzumab; UNK, unknown.\u003c/p\u003e\n\u003cp\u003eOne hundred and seventeen patients had II stages of the disease according to the AJCC system classification (43%), 31% and 22% of patients had stage I and III respectively. Patients received different chemotherapy regimens, mainly anthracyclines containing regimens (78.2%) and in the adjuvant setting (77.4%)\u003c/p\u003e\n\u003cp\u003e4.2 Scalp Cooling Efficacy\u003c/p\u003e\n\u003cp\u003eThe scalp cooling device success rate (Dean\u0026rsquo;s alopecia scale score 0-2 equal to a hair loss \u0026le; 50%) was 72% for all evaluable patients at the end of chemotherapy treatment (248 out of 252). Differences in response to SC device according to the chemotherapy regimens were listed in Table 2.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2\u003c/strong\u003e Features related to chemotherapy regimens used and hair loss degree evaluated by medical staff at the end of all cycles of chemotherapy\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"643\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eChemotherapy regimens\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTreatment completed\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. \u0026nbsp;(%) of Patients\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair loss \u0026le; 50%\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. \u0026nbsp;(%) of Patients\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair loss \u0026gt;50%\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. \u0026nbsp;(%) of Patients\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTreatment prematurely stopped (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eReason \u0026nbsp;(n)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEC\u0026rarr;TXL weekly\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e59 (81.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e39 (66.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e20 (33.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e13 (18.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003eAlopecia (7), coldness (3), others (3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e64 (88.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e41 (64.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e23 (35.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e8 (11.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003eAlopecia (2), pain (2), others (2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTXL + TRAST. Weekly\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e46 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e46 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEC\u0026rarr;TXL+TRAST.weekly\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e27 (80%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e18 (66.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e9 (33.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e8 (22.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003eAlopecia (5), coldness (1), other (1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEC\u0026rarr;TXL + CBDCA weekly\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e5 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e2 (40%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e3 (60%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEC\u0026rarr;TXL+TRAST.+PERT. weekly\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e3 (60%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e3 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e2 (40%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003eOthers (2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e(TXL+CBDCA weekly\u0026rarr;EC )+PEMBRO.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e4 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e4 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e5 (80%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e3 (75%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e1 (25%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e1 (20%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003eAlopecia\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEC\u0026rarr;CMF\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e2 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e1 (50%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eCBDCA+TXL+TRAST. Weekly\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e1 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e1 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"20.87227414330218%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEC\u0026rarr;CMF+TRAST\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.862928348909657%\" valign=\"top\"\u003e\n \u003cp\u003e1 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.18380062305296%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.314641744548286%\" valign=\"top\"\u003e\n \u003cp\u003e1 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.08411214953271%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.682242990654206%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAbbreviation: TXL, paclitaxel; TRAST, trastuzumab; CBDCA, carboplatin; EC, epirubicin \u0026ndash; cyclophosphamide; TC, docetaxel - \u0026nbsp;cyclophosphamide; PEMBRO., pembrolizumab; CMF, \u0026nbsp;cyclophosphamide-methotrexate-5-fluorouracil; PERT., pertuzumab;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Efficacy of 100% in preventing hair loss \u0026gt; 50% was observed in all patients undergoing paclitaxel weekly-based chemotherapy. Moreover, among 46 patients treated with weekly paclitaxel-based chemotherapy (forty-five received paclitaxel-trastuzumab and one paclitaxel-carboplatin-trastuzumab regimen) no one has had a hair loss evaluated by Dean\u0026apos;s scale more than G1 and the majority (42 out of 46) did not experienced any hair loss (G0 according to Dean\u0026apos;s scale). Even if only four patients received chemotherapy with anthracyclines after weekly paclitaxel, all these patients had hair loss \u0026nbsp;\u0026le; 50% (Figure 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eThe hair loss degree related to anthracycline based versus anthracycline free regimes\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"641\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.804992199687987%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eVariable\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.960998439937597%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair loss \u0026le; 50%\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. \u0026nbsp; \u0026nbsp; (%) of Patients\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.117004680187208%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair loss \u0026gt;50% (%)\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. \u0026nbsp; \u0026nbsp; (%) of Patients\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.117004680187208%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.804992199687987%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnthracycline free chemoterapy\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.960998439937597%\" valign=\"top\"\u003e\n \u003cp\u003e49 (98.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.117004680187208%\" valign=\"top\"\u003e\n \u003cp\u003e1 (2.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.117004680187208%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026lt;0.001*\u003c/p\u003e\n \u003cp\u003e(Cramer\u0026rsquo;s V: 0.310)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.125%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnthracycline free chemoterapy\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e108 (65.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.541666666666664%\" valign=\"top\"\u003e\n \u003cp\u003e57 (34.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;p-value: Fisher\u0026rsquo;s exact test; *anthracycline based chemotherapy versus anthracycline free chemotherapy\u003c/p\u003e\n\u003cp\u003eIn our series, hair thickness, hair straightening and hair permanent were related to the risk of hair loss; hair structure, previous alopecia, dyed hair and hair density were not significantly related to scalp-cooling failure (Table 4 and Table 5)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 4. The hair loss degree according to the hair\u0026rsquo;s patient characteristics at baseline.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"567\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eN (%) of Patients\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair loss \u0026le; 50%\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. of Patients (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair loss \u0026gt; 50%\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. of Patients (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.347442680776014%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-Value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair thickness\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eFine\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e76 (30.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e59 (77.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e17 (22.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.347442680776014%\" rowspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0,02*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eMedium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e94 (37.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e72 (76.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e22 (23.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eThick\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e79 (31.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e47 (59.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e32 (40.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair structure\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eStraight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e127 (51%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e97 (76.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e30 (23.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.347442680776014%\" rowspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0,07*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eWavy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e88 (36%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e61 (69.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e27 (30.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eCurly\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e32 (13%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e18 (56.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e14 (43.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair density\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eLow\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e156 (63.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e109 (69.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e47 (30.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.347442680776014%\" rowspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0,64*\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eMedium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e88 (35.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e64 (72.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e24 (27.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eHigh\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e3 (1.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e3 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePevious alopecia\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e10 (4.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e10 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.347442680776014%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e0,67*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e237 (95.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e166 (70.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e71 (30.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDyed hair\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e171 (69%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e121 (70.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e51 (29.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.347442680776014%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e0,64*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e76 (31%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e56 (73.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e20 (26.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair straightening\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e37 (15%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e144 (68.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e66 (31.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.347442680776014%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e0,03*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e210 (85%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e32 (86.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e5 (13.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair permanent\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e8 (3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e7 (88%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e1 (13%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.347442680776014%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e0,44*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e239 (97%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.90272373540856%\" valign=\"top\"\u003e\n \u003cp\u003e169 (71%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"25.09727626459144%\" valign=\"top\"\u003e\n \u003cp\u003e70 (29%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*p-value: Fischer\u0026rsquo;s exact test.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 5. The hair loss degree according to the patient characteristics.\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"567\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eVariables\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair loss \u0026le; 50%\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. of Patients (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair loss \u0026gt; 50%\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN. of Patients (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.964788732394366%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-Value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eBMI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003eOverweight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e61 (80.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e15 (19.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.964788732394366%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e0,003*\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eHealthy weight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e82 (64.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e46 (35.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eUnderweight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e5 (50.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e5 (50.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eObese\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e29 (87.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e4 (12.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSmokers\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e22 (84.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e4 (15.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.964788732394366%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e0,114*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e137 (69.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e61 (30.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003eUnder 50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e94 (69.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e41 (30.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.964788732394366%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e0,480*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eOver 50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e83 (74.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e29 (25.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMenopausal status\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.964788732394366%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003ePremenopausal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e91 (67.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.345070422535212%\" valign=\"top\"\u003e\n \u003cp\u003e44 (32.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.964788732394366%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e0,117*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003ePostmenopausal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e83 (76.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003e25 (23.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*p-value: Fischer\u0026rsquo;s exact test.\u003c/p\u003e\n\u003cp\u003eUnivariate and multivariate logistic regression analysis of hair loss degree according to the patient and treatment characteristics were reported in Table 6. The multivariate analysis identified the type of chemotherapy regimen, BMI and high hair thickness as independent factors for hair loss.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 6. Univariate and multivariate analysis\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"567\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.614840989399294%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eVariable\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"36.042402826855124%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eUnivariate\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"41.342756183745585%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMultivariate\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"29.38496583143508%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOR (95% CI)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.312072892938495%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-Value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"34.39635535307517%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOR (95% CI)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.906605922551254%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-Value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnthracycline based chemotherapy\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"26.069246435845216%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.272912423625254%\" valign=\"top\"\u003e\n \u003cp\u003e25.1743 (3.387-187.096)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.75356415478615%\" valign=\"top\"\u003e\n \u003cp\u003e21.447 (2.845-161.676)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.90427698574338%\" valign=\"top\"\u003e\n \u003cp\u003e0.003*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair thickness\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eMedium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eFine -Medium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e0,918 (0.402-2.096)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e0.838\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e1.031 (0.419-2.535)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e0.946\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eThick - Medium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e2.490 (1.218-5.091)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e0.012\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e2.577 (1.185-5.601)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e0.017*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair straightening\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e0.428 (0.157-1.165)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e0.097\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e0.391 (0.132-1.162)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e0.091\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHair permanent\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e0.385 (0.0463-3.202)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e0.377\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eBMI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eHealthy Weight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eOverweight-Healthy weight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e0.438 (0.2242-0.857)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e0,016\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e0.549 (0.247-1.219)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e0.141\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eUnder-weight-Healty-weight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e1.783 (0.4902-6.483)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e0,380\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e3.519 (0.724-17.099)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e0.119\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.57495590828924%\" valign=\"top\"\u003e\n \u003cp\u003eObese-Healthy-weight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.75132275132275%\" valign=\"top\"\u003e\n \u003cp\u003e0.246 (0.0814-0.743)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.403880070546737%\" valign=\"top\"\u003e\n \u003cp\u003e0,013\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.631393298059965%\" valign=\"top\"\u003e\n \u003cp\u003e0.250 (0.067-0.926)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.638447971781305%\" valign=\"top\"\u003e\n \u003cp\u003e0.038*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*p-value \u0026lt; 0.05\u003c/p\u003e\n\u003ch2\u003e4.3 Adverse Events\u003c/h2\u003e\n\u003cp\u003eSixty-nine percent of all evaluable patients had almost one adverse event, 13% of them early interrupted the use SC system, the majority within the first cycles. The most frequent cause was incoming alopecia in 15 patients (47%). Fear of scalp metastases was the reason of early discontinuation in one patient. Five patients early discontinued due to coldness and two patients due to cervical pain and headache respectively.\u003c/p\u003e\n\u003cp\u003eTable 7 show the frequencies of the adverse events associated with the SC device reported by patients. Coldness was the most frequently adverse event registered in 152 out of 247 (62%) patients, severe in 43%. The second most common adverse event was headache (129/247), mostly mild in gravity (24%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 7. Frequencies of\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eSC\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;adverse events and their gravity according to the patient\u0026rsquo;s description.\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"567\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.871252204585538%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAdverse Events\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.756613756613756%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eNo (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.932980599647266%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.46031746031746%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMild (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eModerate (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSevere (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.871252204585538%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHeadache\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.756613756613756%\" valign=\"top\"\u003e\n \u003cp\u003e118 (47.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.932980599647266%\" valign=\"top\"\u003e\n \u003cp\u003e129 (52.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.46031746031746%\" valign=\"top\"\u003e\n \u003cp\u003e66 (51.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e39 (30.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e24 (18.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.871252204585538%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eScalp Pain\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.756613756613756%\" valign=\"top\"\u003e\n \u003cp\u003e138 (55.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.932980599647266%\" valign=\"top\"\u003e\n \u003cp\u003e109 (44.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.46031746031746%\" valign=\"top\"\u003e\n \u003cp\u003e54 (49.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e37 (33.6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e19 (17.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.871252204585538%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eNeck Pain\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.756613756613756%\" valign=\"top\"\u003e\n \u003cp\u003e147 (59.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.932980599647266%\" valign=\"top\"\u003e\n \u003cp\u003e100 (40.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.46031746031746%\" valign=\"top\"\u003e\n \u003cp\u003e49 (49.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e35 (35.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e15 (15.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.871252204585538%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eColdness\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.756613756613756%\" valign=\"top\"\u003e\n \u003cp\u003e94 (38.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.932980599647266%\" valign=\"top\"\u003e\n \u003cp\u003e153 (61.9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.46031746031746%\" valign=\"top\"\u003e\n \u003cp\u003e54 (35.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e36 (23.8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e61 (40.4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.871252204585538%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHeavy Head\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.756613756613756%\" valign=\"top\"\u003e\n \u003cp\u003e110 (44.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.932980599647266%\" valign=\"top\"\u003e\n \u003cp\u003e137 (55.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.46031746031746%\" valign=\"top\"\u003e\n \u003cp\u003e51 (37.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e64 (46.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.98941798941799%\" valign=\"top\"\u003e\n \u003cp\u003e22 (16.1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003ch2\u003e4.4 Follow-up\u003c/h2\u003e\n\u003cp\u003eMedian follow-up was 35 months (range 12-62) for 248 evaluable patients; fifteen (6%) patients had a relapse of breast cancer. The site of relapse was known in ten patients: one local, six in the liver, two in the brain and one in the bone. At the end of the data cut-off, 11 died for breast cancer relapse (4.4%). No scalp metastasis was reported among the study participants.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eChemotherapy-induced alopecia is one of the most stressful adverse event for breast cancer patients. Our prospective observational analysis confirmed the possibility of avoiding CIA with the use of the scalp cooling system (DigniCap®) in the majority of early breast cancer patients. These data, collected in our center in a larger number of patients, confirmed our previously reported results [13]: overall hair preservation rate was observed in 72% of patients, also in those who received an anthracycline-based chemotherapy regimen (78% of the total population) and only 34.5% of them experienced hair loss \u0026gt; 50%. In line with the literature, we found a statistically significant difference in the efficacy of the scalp cooling system according to the use of anthracyclines (p \u0026lt; 0.001). Moreover, all 46 of patients treated with a weekly paclitaxel-based chemotherapy had a success rate of 100%, with the majority of them (42 out of 46) with hair loss G0 according to the Dean’s scale of alopecia. These results are consistent with two other prospective studies both evaluating the efficacy of the use of the DigniCap® scalp cooling system in preventing CIA in early breast cancer patients. Giarratano et al, showed an overall success rate of 60% which was higher in non-anthracycline (71%) than in anthracycline-based regimens (54%, p\u0026lt;0.001) [15]. Carbognin et al, reported hair preservation in 88% of patients in taxane-based (docetaxel or paclitaxel) chemotherapy group compared to 60.2% in anthracycline and taxane-based chemotherapy group (p \u0026lt; 0.001) with also a 100% success rate in the paclitaxel alone group [16]. In our study the multivariate analysis identified the chemotherapy regimen as an independent risk factor for hair loss, remarking that chemotherapy with anthracycline increased the risk of alopecia when compared to non-anthracycline chemotherapy regimens also with the use of scalp cooling system.\u003c/p\u003e\n\u003cp\u003eAnother prospective study conducted in 2021 evaluated 163 early breast cancer patients eligible for adjuvant therapy. This study confirmed that with the use of the DigniCap® scalp cooling system, hair preservation was successful in 57% of patients in the overall series, reaching 81% of success in the patient subgroup treated with a paclitaxel and trastuzumab regimen. Side effects (feeling cold, headache, head heaviness, scalp and cervical pain) were mild to moderate and did not correlate with the rate of hair loss [17]. \u003c/p\u003e\n\u003cp\u003eSeveral studies have found that some patients' characteristics as nicotine abuse, premenopausal status or some hair’s features like hair density, hair structure and thickness were associated with scalp cooling system outcomes. [16-18]. In our analysis we confirmed the relationship between hair thickness and scalp cooling system efficacy, but we also reported a relationship with hair straightening and hair permanent. Moreover, we found a statistically significance relation between high BMI and hair loss of less than 50%, which was never found before. These data were confirmed by the multivariate analysis. Many reasons can be hypothesized to explain this data. Overweight or obese women with breast cancer often received a reduced dose of cytotoxic drugs, based on ideal body weight [19]. Another reason for this association might be related to the lower relative dose intensity (RDI) of anthracycline and taxane-based chemotherapy due to excess adiposity [20]. Both these possible explanations might explain a lower rate or intensity of CIA, especially if associated with the use of scalp hypothermia, but these associations should be further investigated.\u003c/p\u003e\n\u003cp\u003eIn our study, 13% of patients discontinued the use of the device early, mainly for adverse events. This data is in line with results reported in literature where a percentage of discontinuation ranging from 10% to 13% was reported.\u003c/p\u003e\n\u003cp\u003eWith a median follow-up of 35 months, only 6% of patients had a relapse of the disease, no one had skin scalp metastases and only two progressed in the central nervous system. One of the most frequent worries of the patients and concerns of physicians about SC system is the hypothetical increased risk of cutaneous scalp relapse due to the lower concentration of the chemotherapy in their vessels. In 2017, a systematic review and meta-analysis of longitudinal studies was undertaken to evaluate the effect of scalp cooling versus no scalp cooling on the risk of scalp metastasis in breast cancer patients treated with chemotherapy. The study showed a very low incidence rate of scalp metastasis in the scalp cooling group versus the no scalp cooling group (0.61% versus 0.41%, P=0.43) suggesting that the use of scalp hypothermia to prevent CIA did not increase the incidence of scalp metastases [21]. Few data are available on the risk of central nervous system metastases and in our series only two patients, both with HER-2 positive disease, experienced CNS metastasis as first recurrence .\u003c/p\u003e\n\u003cp\u003eIn conclusion, our data confirmed prospectively the scalp cooling efficacy in a large number of patients enrolled in a single oncological center; efficacy and tolerability of the scalp cooling system are in line with that found in the literature with an overall success rate of 72% and of 100% for patients undergoing a weekly paclitaxel chemotherapy regimen, thus confirming the results of our previous analysis in a larger number of patients without new or long term toxicity or particular concerns with a longer follow-up. However, some limitations need to be highlighted. The present study was observational and didn't collect data about global patients personal experience, quality of life, the contemporary use of an headgear, dermatological analysis of the hair status by a specialist at baseline and at the end of the treatment.\u003c/p\u003e\n\u003cp\u003eDespite these considerations, the use of the scalp cooling device like DigniCap® is an important equipment to offer to early breast cancer patients to improve compliance to treatments, outcome and quality of life.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCIA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eChemotherapy-induced alopecia\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBreast cancer\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eEC/AC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eEpirubicin/Adriamiycin and cyclophosphamide\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eWHO\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eWorld Health Organization\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHormone Receptors\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHER2\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHuman Epidermal Growth Factor Receptor 2\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTXL\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePaclitaxel\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCTLA-4\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eT-lymphocyte-associated protein-4\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePD-1\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eProgrammed cell Death protein-1\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePD-L1\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eProgrammed Death-Ligand-1\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHFs\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eScalp hair follicles\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eScalp Cooling\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFDA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFood and Drug Administration\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eChemotherapy\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that no funds, grants, or other support were received during the preparation of this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no relevant financial or non-financial interests to disclose.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors contributed to the study's conception and design. Material preparation and data collection were performed by Dario Loparco, Annamaria Quaranta, Paola Schiavone, Chiara Caliolo, Mariangela Pasqualoni and Mariangela Rendini. The first draft of the manuscript was written by Mariangela Pasqualoni and Laura Orlando. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformed consent was obtained from all individual participants included in the study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003e\u0026laquo;Breast C (2022) \u0026ndash;2024\u0026raquo; Facts \u0026amp; Figs. s.d\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLoibl S, Andr\u0026eacute; F, Bachelot T, Barrios CH, Bergh J, Burstein HJ, Cardoso LMJ et al (2023) \u0026laquo;Early Breast Cancer: ESMO Clinical Practice Guideline for Diagnosis, Treatment and Follow-Up\u0026dagger;\u0026raquo;. \u003cem\u003eAnnals of Oncology\u003c/em\u003e, dicembre. 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PMID: 26451590\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGriggs JJ, Melony ES, Sorbero H Lyman. \u0026laquo;Undertreatment of Obese Women Receiving Breast Cancer Chemotherapy\u0026raquo;. \u003cem\u003eArchives of Internal Medicine\u003c/em\u003e 165, fasc. 11 (13 giugno 2005): 1267. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1001/archinte.165.11.1267\u003c/span\u003e\u003cspan address=\"10.1001/archinte.165.11.1267\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCespedes Feliciano EM, Wendy Y, Chen V, Lee KB, Albers CM, Prado S, Alexeeff J, Xiao, Shlomit S Shachar, e Bette J. Caan. \u0026laquo;Body Composition, Adherence to Anthracycline and Taxane-Based Chemotherapy, and Survival After Nonmetastatic Breast Cancer\u0026raquo;. \u003cem\u003eJAMA Oncology\u003c/em\u003e 6, fasc. 2 (1 febbraio 2020): 264. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1001/jamaoncol.2019.4668\u003c/span\u003e\u003cspan address=\"10.1001/jamaoncol.2019.4668\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRugo HS, Susan A, Melin eJ, Voigt (2017) \u0026laquo;Scalp Cooling with Adjuvant/Neoadjuvant Chemotherapy for Breast Cancer and the Risk of Scalp Metastases: Systematic Review and Meta-Analysis\u0026raquo;. \u003cem\u003eBreast Cancer Research and Treatment\u003c/em\u003e 163, fasc. 2giugno : 199\u0026ndash;205. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s10549-017-4185-9\u003c/span\u003e\u003cspan address=\"10.1007/s10549-017-4185-9\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"scalp-cooling, breast cancer, chemotherapy-induced alopecia, quality of life, DigniCap®","lastPublishedDoi":"10.21203/rs.3.rs-4830396/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4830396/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eChemotherapy-induced alopecia (CIA) negatively impacts quality of life of breast cancer patients. The present observational study was designed to confirm the efficacy and safety of scalp-cooling system to prevent CIA in early breast cancer (BC) patients undergoing (neo)adjuvant chemotherapy.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe prospectively evaluated all early BC patients undergoing scalp cooling during (neo)adjuvant chemotherapy in our Institution. Primary endpoint was to assess the success of scalp cooling system (hair loss\u0026thinsp;\u0026le;\u0026thinsp;50%).\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eWe included 252 early breast cancer patients treated from May 2016 to July 2023; median age was 49 years, 46% had stage II disease. Most of them received adjuvant chemotherapy (77.4%) and anthracycline-based regimens (78.2%). Hair loss\u0026thinsp;\u0026le;\u0026thinsp;50% was observed in 72% of overall patients: in all patients treated with paclitaxel weekly-based chemotherapy, and in 63% and 75% of pts treated with anthracycline and docetaxel-cyclophosphamide regimens respectively (anthracycline-based versus anthracycline-free regimens, p\u0026thinsp;\u0026le;\u0026thinsp;0.05). Hair thickness, straightening, permanent hair and BMI were factors linked to the risk of hair loss (p\u0026thinsp;\u0026le;\u0026thinsp;0.05). Sixty-nine percent of patients had almost one adverse event, coldness the most frequent (62%); 13% of patients early discontinued the use of the scalp cooling system. With a median months of follow-up of 35 months, no scalp metastasis was reported.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThese results support the use of scalp-cooling in preventing CIA for early breast cancer patients receiving (neo)adjuvant chemotherapy especially if they underwent anthracycline-free regimens, reducing the negative psychological impact of oncological treatments on their lives.\u003c/p\u003e","manuscriptTitle":"Scalp Cooling in Preventing Chemotherapy-Induced Alopecia for Early Breast Cancer Patients: Long-Term Outcomes of Real- Life Data","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-09-03 11:42:55","doi":"10.21203/rs.3.rs-4830396/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"57a6c32e-8774-486b-8e8c-8468cf4ba3a9","owner":[],"postedDate":"September 3rd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-12-30T14:54:04+00:00","versionOfRecord":[],"versionCreatedAt":"2024-09-03 11:42:55","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4830396","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4830396","identity":"rs-4830396","version":["v1"]},"buildId":"omnImTCwR2MFx8CMYfrG7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}