Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial.
Support Care Cancer
; 31(12): 644, 2023 Oct 18.
Article
em En
| MEDLINE
| ID: mdl-37851095
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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Xerostomia
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Radioterapia (Especialidade)
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Neoplasias de Cabeça e Pescoço
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article