Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
Data Collection
Radiation Fibrosis Syndrome+10
+ Breast Diseases
+ Breast Neoplasms
Supportive Care Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.63 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Hull Royal Infirmary
Hull, United KingdomLondon Hyperbaric Medicine Limited at Whipps Cross Hospital
London, United KingdomDiving Diseases Research Centre
Plymouth, United Kingdom