Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077090
Recruitment Status : Unknown
Verified September 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 11, 2004
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Lymphedema Perioperative/Postoperative Complications Radiation Fibrosis Drug: hyperbaric oxygen Phase 2

Detailed Description:



  • 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.


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
Study Start Date : April 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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
  2. 99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
  3. Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18


  • Female or male

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No chronic obstructive airway disease
  • No bullous lung disease
  • No acute or chronic pulmonary infection
  • No uncontrolled asthma
  • No untreated pneumothorax


  • 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)


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics
  • No prior ear operations


  • No prior hyperbaric oxygen (HBO) therapy, except as treatment for decompression illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077090

Layout table for location information
United Kingdom
Royal Hospital Haslar
Gosport, England, United Kingdom, PO12 2AA
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
London Hyperbaric Medicine Limited at Whipps Cross Hospital
London, England, United Kingdom, E11 1NR
Diving Diseases Research Centre
Plymouth, England, United Kingdom, PL6 8BU
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Layout table for investigator information
Study Chair: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
Layout table for additonal information Identifier: NCT00077090    
Other Study ID Numbers: CDR0000349496
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: September 2007
Keywords provided by National Cancer Institute (NCI):
radiation fibrosis
perioperative/postoperative complications
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Radiation Pneumonitis
Postoperative Complications
Neoplasms by Site
Breast Diseases
Skin Diseases
Pathologic Processes
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Radiation Injuries
Wounds and Injuries