Hyperbaric Oxygen Therapy for Radiation Induced Xerostomia (Dry Mouth)
Hyperbaric oxygen therapy versus control to assess affect on quality of life and saliva analysis in patients with established xerostomia following radiotherapy in head and neck cancer.
Dr S Sherlock
60 participants
Apr 24, 2012
Interventional
Conditions
Summary
This study will assess the effect of hyperbaric oxygen therapy on quality of life and saliva in patients with dry mouth (xerostomia) following radiotherapy for head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18-90 years and have been diagnosed with xerostomia of at least 6 months duration following radiotherapy for head and neck cancer. Trial details Participants in this trial will be randomly (by chance ) allocated to one of two groups. Participants in one group will undergo 30 daily hyperbaric oxygen treatments of 90 minutes duration each. Participants in the other group will receive 30 placebo (control) treatments initially but will be offered the hyperbaric oxygen treatment after 3 months. Participants will not know which group they are in until the trial is completed. Participants will be regularly assessed over a 12 month period to determine their quality of life, saliva components and treatment costs.
Eligibility
Inclusion Criteria3
- head and neck cancer with radiation therapy>50Gy
- established xerostomia of at least 6 months duration
- no contraindiations to hyperbaric oxygen therapy
Exclusion Criteria1
- Contraindication to hyperbaric therapy
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Interventions
Hyperbaric oxygen therapy at 2.4 ATA for 30 treatments. Each treatment is 90 mins, daily (Mon-Fri) for 6 weeks.This would be at least 6 months after completion of radiotherapy.The treatment is given in a monoplace hyperbaric chamber so no hoods/ masks are required.
Locations(1)
View Full Details on ANZCTR
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ACTRN12612000084886