Overview

This trial is active, not recruiting.

Conditions breast cancer, lymphedema, perioperative/postoperative complications, radiation fibrosis
Treatment hyperbaric oxygen
Phase phase 2
Sponsor Institute of Cancer Research, United Kingdom
Start date April 2004
Trial size 63 participants
Trial identifier NCT00077090, CDR0000349496, EU-20337, RMNHS-HOT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose supportive care

Primary Outcomes

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
time frame:

Secondary Outcomes

Measure
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
time frame:
99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
time frame:
Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).