Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for early breast cancer (HOT) - HOT
- Conditions
- Chronic radiation-induced arm lymphoedema.
- Registration Number
- EUCTR2004-004952-38-GB
- Lead Sponsor
- Prof John Yarnold, Institute of Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 63
Past history of surgery and radiotherapy for early breast cancer including radiotherapy to the axilla and/or SCF at least 24 months prior to trial entry. Arm lymphoedema (at least 15% increase in arm volume). No evidence of cancer recurrence. Physical and psychological fitness for hyperbaric oxygen therapy. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Prior hyperbaric oxygen therapy, claustrophobia, epilepsy. Chronic obstructive airways disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated phneumothorax. Previous ear operations, eustachian tube dysfunction or recurrent attacks of vertigo.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary aim of the trial is to test the efficacy of hyperbaric oxygen therapy in reducing arm lymphoedema in patients suffering long-term adverse effects of high dose radiotherapy for early breast cancer. ;Secondary Objective: A secondary aim is to test mechanisms of tissue reperfusion and healing in response to hyperbaric oxygen therapy.;Primary end point(s): Volume of the affected limb expressed as a percentage of the contralateral limb volume on the day of measurement.
- Secondary Outcome Measures
Name Time Method