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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Lymphedema; Perioperative/Postoperative Complications; Radiation Fibrosis
• Intervention / Treatment: Drug: hyperbaric oxygen

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 Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Gosport, England, United Kingdom, PO12 2AA
      • Royal Hospital Haslar
    • Hull, England, United Kingdom, HU3 2KZ
      • Hull Royal Infirmary
    • London, England, United Kingdom, E11 1NR
      • London Hyperbaric Medicine Limited at Whipps Cross Hospital
    • Plymouth, England, United Kingdom, PL6 8BU
      • Diving Diseases Research Centre
    • Sutton, England, United Kingdom, SM2 5PT
      • Royal Marsden NHS Foundation Trust - Surrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Investigators: Study Chair: John R. Yarnold, MD, FRCR, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: April 1, 2004

Study Registration Dates

• First Submitted: February 10, 2004
• First Submitted That Met QC Criteria: February 10, 2004
• First Posted (Estimate): February 11, 2004

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: September 1, 2007

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage II breast cancer; stage I breast cancer; lymphedema; perioperative/postoperative complications; radiation fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lymphatic Diseases; Lung Diseases; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Fibrosis; Breast Neoplasms; Lymphedema; Postoperative Complications; Radiation Pneumonitis
• Other Study ID Numbers: CDR0000349496; RMNHS-HOT; EU-20337