Breast Cancer Clinical Trial
Official title:
Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and
reducing lymphedema caused by radiation therapy for cancer.
PURPOSE: This randomized phase II trial is studying hyperbaric oxygen to see how well it
works compared to standard therapy in treating chronic arm lymphedema in patients who have
undergone radiation therapy for cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO
therapy.
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
weeks.
- Arm II: Patients receive standard management. Patients are followed at 3, 6, 9, 12, and
15 months.
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
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