Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
- Compare the efficacy of hyperbaric oxygen (HBO) therapy vs standard management, in
terms of reduction of lymphedema, in patients with chronic arm lymphedema after
radiotherapy for cancer.
- Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo hyperbaric oxygen therapy over 90 minutes 5 days a week for 6
- Arm II: Patients receive standard management. Patients are followed at 3, 6, 9, 12, and
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 63 patients (42 for arm I and 21 for arm II) will be accrued
for this study.
Allocation: Randomized, Primary Purpose: Supportive Care
Volume of the affected limb, expressed as a percentage of the contralateral limb Volume on the day of measurement, as measured by perometer 12 months after baseline assessment
John R. Yarnold, MD, FRCR
Royal Marsden NHS Foundation Trust
United States: Federal Government