Breast Cancer, Lymphedema, Perioperative/Postoperative Complications, Radiation Fibrosis
Conditions
Keywords
lymphedema, radiation fibrosis, perioperative/postoperative complications, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
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.
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.
Interventions
DRUGhyperbaric oxygen
Sponsors
Institute of Cancer Research, United Kingdom
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed