Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Closed Over 18 Other RMNHS-HOT EU-20337, NCT00077090

Objectives

Primary

1. 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

1. Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO therapy.

Entry 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

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

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)

Expected Enrollment

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

Outcomes

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

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

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

Trial Contact Information

Trial Lead Organizations

Institute of Cancer Research - Sutton

John Yarnold, MD, FRCR, Protocol chair		Ph: 44-20-8661-3388

Registry Information
Official Title		Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
Trial Start Date		2004-04-01
Registered in ClinicalTrials.gov		NCT00077090
Date Submitted to PDQ		2003-12-10
Information Last Verified		2007-09-16

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