Visco-ease RIX Study - V1.0
Research type
Research Study
Full title
Assessing the safety and effectiveness of Visco-ease for the treatment of Radiotherapy Induced Xerostomia in head and neck cancer patients.
IRAS ID
163646
Contact name
Claire Paterson
Contact email
Sponsor organisation
Greater Glasgow Health Board,
ISRCTN Number
ISRCTN44528835
Duration of Study in the UK
0 years, 11 months, 20 days
Research summary
Following radiotherapy to the head and neck area patients can suffer from dry mouth (radiotherapy induced xerostomia - RIX). This is due to an increase in saliva thickness and stickiness. It can be unpleasant and cause problems with speech, dental health, eating, drinking and swallowing. At present there is no proven treatment for this side effect of radiotherapy.
Visco-ease is a new product developed for the treatment of dry mouth during radiotherapy. Previous work suggests that Visco-ease can change the thick, sticky saliva experienced after radiotherapy back to less sticky, thinner saliva. Although this is a ‘first in man’ study of this investigational device, the components of Visco-ease have all been studied extensively and are natural and common in many foods. Visco-ease is designed to act on the surface of the mouth.
During this study, patients receiving radiotherapy for head and neck cancer will administer Visco-ease spray or “placebo” (a dummy device with no action) under their tongue, for the duration of the radiotherapy treatment (6 weeks). Patients will also be asked to tell us about how bad they feel their dry mouth and sticky saliva is, how it affects everyday activities and if the spray makes any difference to these symptoms. This information will be obtained by asking the patient to complete a short questionnaire and diary.
This study aims to look at how Visco-ease may help patients with RIX.REC name
West of Scotland REC 4
REC reference
15/WS/0281
Date of REC Opinion
14 Dec 2015
REC opinion
Favourable Opinion