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Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer.
- Source :
-
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology [Radiother Oncol] 2010 Oct; Vol. 97 (1), pp. 101-7. Date of Electronic Publication: 2010 May 31. - Publication Year :
- 2010
-
Abstract
- Background: A non-randomised phase II study suggested a therapeutic effect of hyperbaric oxygen (HBO) therapy on arm lymphoedema following adjuvant radiotherapy for early breast cancer, justifying further investigation in a randomised trial.<br />Methods: Fifty-eight patients with ≥ 15% increase in arm volume after supraclavicular ± axillary radiotherapy (axillary surgery in 52/58 patients) were randomised in a 2:1 ratio to HBO (n=38) or to best standard care (n=20). The HBO group breathed 100% oxygen at 2.4 atmospheres absolute for 100 min on 30 occasions over 6 weeks. Primary endpoint was ipsilateral limb volume expressed as a percentage of contralateral limb volume. Secondary endpoints included fractional removal rate of radioisotopic tracer from the arm, extracellular water content, patient self-assessments and UK SF-36 Health Survey Questionnaire.<br />Findings: Of 53/58 (91.4%) patients with baseline assessments, 46 had 12-month assessments (86.8%). Median volume of ipsilateral limb (relative to contralateral) at baseline was 133.5% (IQR 126.0-152.3%) in the control group, and 135.5% (IQR 126.5-146.0%) in the treatment group. Twelve months after baseline the median (IQR) volume of the ipsilateral limb was 131.2% (IQR 122.7-151.5%) in the control group and 133.5% (IQR 122.3-144.9%) in the treatment group. Results for the secondary endpoints were similar between randomised groups.<br />Interpretation: No evidence has been found of a beneficial effect of HBO in the treatment of arm lymphoedema following primary surgery and adjuvant radiotherapy for early breast cancer.<br /> (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)
- Subjects :
- Chronic Disease
Endpoint Determination
Female
Humans
Lymph Nodes radiation effects
Lymphedema diagnostic imaging
Middle Aged
Quality of Life
Radionuclide Imaging
Risk Factors
Statistics, Nonparametric
Surveys and Questionnaires
Treatment Outcome
Arm diagnostic imaging
Breast Neoplasms radiotherapy
Hyperbaric Oxygenation
Lymphedema etiology
Lymphedema therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1879-0887
- Volume :
- 97
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 20605648
- Full Text :
- https://doi.org/10.1016/j.radonc.2010.04.026