Sodium-hyaluronate Mouthwash on Radiotherapy-induced Xerostomia: a Randomized Clinical Trial

Abstract

Introduction: Radiotherapy-Induced Xerostomia (RIX) is one of the most common adverse effects of Radiotherapy (RT) in the Head and Neck Cancer patients (HNC), and a major determinant of survivors' quality of life. The primary objective was to evaluate the reduction of patients’ xerostomia symptoms after the utilization of a sodium-hyaluronate mouthwash compared to a placebo solution. The secondary objectives were to evaluate the improvement of quality of life, and to evaluate the patients’ satisfaction. Methods: The protocol was approved by the ethical committee (Ref. 50053/19) and registered at ClinicalTrials.gov (ID: NCT05103124). The study was a double-blind randomized clinical trial (RCT) with a crossover design and was conducted the Fondazione Policlinico Universitario A. Gemelli, Rome Results: Thirty-two patients completed the study protocol. Lower values of the modified Xerostomia Questionnaire (XQ) were retrieved when comparing the baseline scores to the ones after treatment, when compared with placebo (Mann-Whitney U test = 0.01); higher values of patients’ satisfaction (Likert Scale) and modified XQ were retrieved for the sodium-hyaluronate mouthwash (Mann-Whitney U test = 0.001). Conclusions: This RCT highlight the advantages of treating RIX with the sodium-hyaluronate mouthwash, since it seems to be clinically effective in reducing its symptoms, without any reported adverse events.