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

Institute of Cancer Research, United Kingdom

Status and phase: Unknown; Phase 2

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

Treatments: Drug: hyperbaric oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT00077090

RMNHS-HOT

EU-20337

CDR0000349496

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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