Stem Cell Transplantation Patients Receiving a Novel Oral Care Protocol for Oral Mucositis Prevention and Treatment: Patient-reported Outcomes and Quality of Life

Abstract Background: Oral mucositis (OM) is one of the most debilitating effects of toxicity due to hematopoietic stem cell transplantation (HSCT) conditioning regimens. The aim of this secondary analysis of the data of a phase II study designed to assess the efficacy of a novel oral care protocol containing bovine colostrum and aloe vera to prevent oral mucositis was to compare outcomes reported by patients with those collected by healthcare professionals (HCPs). Method: Data on oral mucositis severity, duration, time of onset and related pain were collected from patients using the Oral Mucositis Daily Questionnaire (OMDQ). HCPs assessed the same outcomes using the World Health Organization oral mucositis scale and pain numerical rating scale. Quality of life was assessed with the 3-level EuroQol-5 dimensions.Results: Fifty-nine autologous/ allogeneic graft patients were recruited, 46 of whom (78.0%) experienced OM. Mean onset was 9.1 (SD±3.5) days after conditioning initiation, mean duration was 10.4 (SD±4.3) days and the average maximum pain score was 3.7 (SD±2.7). Self-administration of the OMDQ detected oral symptoms at least 1 day sooner compared to objective assessments (p = 0.025). Significant differences were observed between the patient-reported and the HCP-assessment data on oral mucositis severity grading distribution (p < 0.0001) and highest pain score (p < 0.0001). Quality of life score variations were correlated with changes in oral mucositis severity during patients’ hospital stay. Conclusions: Further studies are necessary to improve the understanding of these findings; a randomized controlled trial is being set up at our institution.