NCT00077090

Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer

Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Cancer
• Lymphedema
• Perioperative/Postoperative Complications
• Radiation Fibrosis

Interventions

Type	Name	Description
DRUG	hyperbaric oxygen

Timeline

• Start date: 2004-04-01
• First posted: 2004-02-11
• Last updated: 2013-12-18

Locations

5 sites across 1 country: United Kingdom