Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
18 Years
N/A
Both
Breast Cancer, Lymphedema, Perioperative/Postoperative Complications, Radiation Fibrosis
Trial Information
Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
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
Principal Investigator
John R. Yarnold, MD, FRCR
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000349496
NCT ID:
NCT00077090
Start Date:
April 2004
Completion Date:
Related Keywords:
- Breast Cancer
- Lymphedema
- Perioperative/Postoperative Complications
- Radiation Fibrosis
- lymphedema
- radiation fibrosis
- perioperative/postoperative complications
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
- Fibrosis
- Lymphedema
- Postoperative Complications
- Radiation Pneumonitis
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