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

Phase 2

• Conditions: Breast Cancer; Lymphedema; Perioperative/Postoperative Complications; Radiation Fibrosis

• Registration Number: NCT00077090
• Lead Sponsor: Institute of Cancer Research, United Kingdom

Brief 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.

Study Timeline

• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-10
• Study First Posted: 2004-02-11
• Study Start: 2004-04
• Status Verified: 2007-09
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Patient self-assessments, using specific quality of life scale in upper limb lymphoedema and the UK SF-36 Health Survey Questionnaire, at 3, 6, 9 and 12 months after baseline assessment
99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment

Trial Locations

Locations (5)

London Hyperbaric Medicine Limited at Whipps Cross Hospital; 🇬🇧 London, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey; 🇬🇧 Sutton, England, United Kingdom

Diving Diseases Research Centre; 🇬🇧 Plymouth, England, United Kingdom

Royal Hospital Haslar; 🇬🇧 Gosport, England, United Kingdom

Hull Royal Infirmary; 🇬🇧 Hull, England, United Kingdom