Author:
Rupe Cosimo,Basco Alessia,Gioco Gioele,Patini Romeo,Lucchese Alberta,Micciché Francesco,Massaccesi Mariangela,Lajolo Carlo
Abstract
Abstract
Introduction
Radiotherapy-induced xerostomia (RIX) is one of the most common adverse effects of radiotherapy (RT) in 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 utilisation 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. 50,053/19) and registered at ClinicalTrials.gov (ID: NCT05103124). The study was a double-blind randomised clinical trial (RCT) with a crossover design and was conducted at 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 the 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 highlights 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.
ClinicalTrials.gov: NCT05103124 in 17/10/2021.
Funder
Università Cattolica del Sacro Cuore
Publisher
Springer Science and Business Media LLC