RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of hyperbaric oxygen therapy with that of standard therapy in treating chronic arm lymphedema in women who have undergone radiation therapy for early breast cancer.

Condition	Treatment or Intervention	Phase
Lymphedema Radiation Fibrosis perioperative/postoperative complications stage I breast cancer stage II breast cancer stage IIIA breast cancer	Drug: hyperbaric oxygen  Procedure: complications of therapy assessment/management  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Compare the efficacy of hyperbaric oxygen (HBO) therapy vs standard management, in terms of reduction of lymphedema, in women with chronic arm lymphedema after radiotherapy for early breast 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.

PROJECTED ACCRUAL: A total of 63 patients (42 for arm I and 21 for arm II) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

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

United Kingdom, England
      Royal Marsden NHS Foundation Trust - Surrey, Sutton,  England,  SM2 5PT,  United Kingdom; Recruiting

Study chairs or principal investigators

John Robert Yarnold, MD,  Study Chair,  Royal Marsden NHS Trust   

Study ID Numbers:  CDR0000349496; RMNHS-HOT; EU-20337; NCT00077090
Record last reviewed:  May 2004
Last Updated:  December 6, 2004
Record first received:  February 10, 2004
ClinicalTrials.gov Identifier:  NCT00077090
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08