Status:
UNKNOWN
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Breast Cancer
Lymphedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 h...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00077090
Start Date
April 1 2004
Last Update
December 18 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Hospital Haslar
Gosport, England, United Kingdom, PO12 2AA
2
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
3
London Hyperbaric Medicine Limited at Whipps Cross Hospital
London, England, United Kingdom, E11 1NR
4
Diving Diseases Research Centre
Plymouth, England, United Kingdom, PL6 8BU