Management of dry mouth following radiation therapy: investigation of a new saliva substitute product.
Not Applicable
- Conditions
- xerostomiaOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12613000827730
- Lead Sponsor
- Jules Kieser
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
It is a requirement that participants have received radiation therapy to the head and neck region within the last 10 years at Christchurch Hospital.
Participants will be asked a global question regarding xerostomia. How often does your mouth feel dry?
Responses are: ‘Never’, ‘Occasionally’, ‘Frequently’, ‘Always’.
Participants who respnd ‘Frequently’ and ‘Always’ will be considered to have xerostomia and will be included in the trial.
Exclusion Criteria
Participants who have had surgery as well as radiation therapy for head and neck cancer will not be included. Those who cannot safely swallow solid food will not be included.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Test of Mastication and Swallowing Solids (TOMASS)[The trial tests responses both immediately and after 1 week of use];Subjective feeling of xerostomia as assessed using the Xerostomia Inventory.<br><br>[The trial tests responses both immediately and after 1 week of use]; Patient acceptability as measured using a visual analogue scale.<br><br>[The trials tests responses both immediately and after 1 week of use]
- Secondary Outcome Measures
Name Time Method nil[nil]