CLINICAL TRIALS

As our mechanistic understanding of the modes of action of hyperbaric oxygen (HBO) therapy improves, new potential applications for the therapy will emerge. At DDRC Healthcare we are committed to performing clinical trials as part of our research portfolio in order to determine which clinical conditions are likely to benefit from this mode of treatment.

We have previously undertaken clinical trials at all levels of complexity, from small, single-centre pilot studies, to large, multi-centre, national and internationally driven randomised controlled trials.

Hyperbaric Oxygen and Radiation Tissue Damage Clinical Trials

A recent focus of our trials has been radiation tissue damage, both in soft tissue (HOT II: HBO and Long-Term Effects of Radiotherapy for Pelvic Cancer) and in bone (HOPON: HBO and Prevention of Osteoradionecrosis for Head and Neck Cancer) and DAHANCA21 (Danish Head and Neck Cancer Association Trial 21: Treatment of Osteoradionecrosis Post Radiotherapy for Head and Neck Cancer).

Osteoradionecrosis can develop in patients who have received radiotherapy for head and neck, particularly following dental extraction in the irradiated area. This condition has a significant effect on quality of life and health, by causing pain and difficulty in eating. Hyperbaric oxygen therapy has been used for many years in both the treatment and prevention of this condition. The HOPON and DAHANCA21 clinical trials aim to add to the available evidence.

Patients suffering long-term adverse effects of radiotherapy for pelvic cancer can feel unable to go about their day-to-day lives, due to the damage caused to the soft tissue in their abdomens. The HOTII trial opened the way for more research into this potentially life-changing treatment through helping to focus on the specific adverse effects most likely to benefit from therapy.

Each of these clinical trials was supported by Cancer Research UK. The results have been published in Lancet Oncology. The HOTII-trial-protocol and the HOTII-clinical-study-report can be downloaded here.

 

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