Hyperbaric Oxygen Therapy for Radiation Induced Xerostomia (Dry Mouth)
Phase 3
- Conditions
- Cancer - Head and neckSoft tissue radiation injury to salivary glands (xerostomia)Head and Neck CancerOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12612000084886
- Lead Sponsor
- Dr S Sherlock
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
head and neck cancer with radiation therapy>50Gy
established xerostomia of at least 6 months duration
no contraindiations to hyperbaric oxygen therapy
Exclusion Criteria
Contraindication to hyperbaric therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life score with XQ scoring system[baseline<br>end of hyperbaric oxygen treatment <br>3 months<br>6 months<br>12 months]
- Secondary Outcome Measures
Name Time Method saliva anlaysis ( pH, flow and consistency). This is tested with a dental kit which allows scoring of saliva flow. The subject need only give a spit sample which is timed over a couple of minutes.[prior to hyperbaric oxygen treatment<br> immediately after hyperbaric oxygen treatment<br>3 months post hyperbaric oxygen treatment];bacterial genomic study of saliva[baseline<br>end of treatment<br>3 months];Dental extraction rate as reported by subject in a diary which is issued to them at commencement of enrolment.[3 months<br>6 months<br>12 months];Participants self report costs as estimated by them in a diary e.g transport to hospital for appointments,saliva analogues, dental visits, speech pathology appointments.[6 months]