Randomised phase II trial of Hyperbaric Oxygen Therapy in patients with chronic arm lymphoedema after radiotherapy for early breast cancer
Phase 2
Completed
- Conditions
- Chronic radiation-induced arm lymphoedema.Circulatory SystemPostprocedural disorders of the circulatory system, not elsewhere classified
- Registration Number
- ISRCTN00743708
- Lead Sponsor
- The Institute of Cancer Research (UK)
- Brief Summary
2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20605648 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 58
Inclusion Criteria
1. Cancer patients with a past history of breast surgery +/- axillary dissection.
2. Past history of radiotherapy to the breast/chest wall +/- axilla and/or supraclavicular fossa (SCF) (at least 2 years prior to trial entry).
3. At least 15% increase in arm volume (compared to the contralateral arm).
4. Physical and psychological fitness for hyperbaric oxygen therapy.
Exclusion Criteria
Evidence of cancer recurrence.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Added 06/08/09:<br> 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<br>
- Secondary Outcome Measures
Name Time Method <br> Added 06/08/09:<br> 1. 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<br> 2. 99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment<br> 3. Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment<br>