Radiotherapy-induced xerostomia: a randomised, double-blind, controlled trial of Visco-ease™ oral spray compared with placebo in patients with cancer of the head and neck.
GRIX
LMS-611
Radiotherapy-induced xerostomia
Visco-ease™
head and neck cancer
Journal
The British journal of oral & maxillofacial surgery
ISSN: 1532-1940
Titre abrégé: Br J Oral Maxillofac Surg
Pays: Scotland
ID NLM: 8405235
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
10
09
2018
accepted:
09
10
2019
pubmed:
2
11
2019
medline:
4
3
2020
entrez:
2
11
2019
Statut:
ppublish
Résumé
Radiotherapy-induced xerostomia (RIX) is a common and untreatable side effect of radiotherapy to the head and neck. Visco-ease™ mouth spray (Lamellar Biomedical Ltd), a new product that is made from lamellar body mimetics, reduces the viscosity of saliva ex vivo. The purpose of this study was to evaluate its safety and effectiveness in the treatment of RIX in 43 patients with cancer of the head and neck. They were randomised into the Visco-ease™ or placebo groups, and asked to complete the Groningen radiotherapy-induced xerostomia (GRIX) questionnaire each week. The primary endpoint was a change in GRIX score from baseline to end of treatment. There was no difference in scores between the two groups, and none of the patients had device-related serious adverse events. Visco-ease™ oral spray was safe and tolerable but no better than placebo in reducing RIX in this group of patients.
Identifiants
pubmed: 31672256
pii: S0266-4356(19)30695-3
doi: 10.1016/j.bjoms.2019.10.300
pii:
doi:
Substances chimiques
Oral Sprays
0
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1119-1125Informations de copyright
Copyright © 2019 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.