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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Lymphedema, Perioperative/Postoperative Complications, Radiation Fibrosis

Intervention / Treatment
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* Drug: hyperbaric oxygen


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: History of early breast cancer (T1-3, N0-1, M0) Prior breast surgery with or without axillary dissection Prior breast/chest wall radiotherapy with or without radiotherapy to the supraclavicular fossa and/or axilla, completed at least 2 years ago Arm lymphedema At least 15% increase in arm volume No evidence of cancer recurrence Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Over 18 Sex Female or male Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Pulmonary No chronic obstructive airway disease No bullous lung disease No acute or chronic pulmonary infection No uncontrolled asthma No untreated pneumothorax Other Physically and psychologically fit for HBO therapy No claustrophobia No epilepsy No eustachian tube dysfunction No recurrent attacks of vertigo No contraindication to MRI (e.g., intracranial ferrous material) PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery See Disease Characteristics No prior ear operations Other No prior hyperbaric oxygen (HBO) therapy, except as treatment for decompression illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hyperbaric oxygen|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, radiation fibrosis, perioperative/postoperative complications, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer