Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
Description:
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.
Condition:
Breast Cancer
Treatment:
hyperbaric oxygen
Start Date:
April 2004
Sponsor:
Institute of Cancer Research, United Kingdom
For More Information:
https://clinicaltrials.gov/show/NCT00077090