Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer
NCT ID: NCT00077090
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
63 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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hyperbaric oxygen
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Principal Investigators
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John R. Yarnold, MD, FRCR
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Royal Hospital Haslar
Gosport, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
London Hyperbaric Medicine Limited at Whipps Cross Hospital
London, England, United Kingdom
Diving Diseases Research Centre
Plymouth, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Countries
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Other Identifiers
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RMNHS-HOT
Identifier Type: -
Identifier Source: secondary_id
EU-20337
Identifier Type: -
Identifier Source: secondary_id
CDR0000349496
Identifier Type: -
Identifier Source: org_study_id