TerminatedPhase 3ACTRN12612000084886

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.


Sponsor

Dr S Sherlock

Enrollment

60 participants

Start Date

Apr 24, 2012

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether hyperbaric oxygen therapy (breathing pure oxygen in a pressurised chamber) can relieve chronic dry mouth caused by radiation treatment for head and neck cancer. Participants aged 18 to 90 must have had dry mouth for at least 6 months after receiving radiation therapy over 50 Gray.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

QLD, Australia

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