Document Detail

Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer.
MedLine Citation:
PMID:  20605648     Owner:  NLM     Status:  MEDLINE    
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.
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.
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.
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.
Lone Gothard; Joanne Haviland; Phil Bryson; Gerard Laden; Mark Glover; Steven Harrison; Mary Woods; Gary Cook; Clare Peckitt; Ann Pearson; Navita Somaiah; Anthony Stanton; Peter Mortimer; John Yarnold
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-05-31
Journal Detail:
Title:  Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology     Volume:  97     ISSN:  1879-0887     ISO Abbreviation:  Radiother Oncol     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-11     Completed Date:  2011-02-04     Revised Date:  2011-03-30    
Medline Journal Info:
Nlm Unique ID:  8407192     Medline TA:  Radiother Oncol     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  101-7     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
Department of Radiotherapy, The Royal Marsden NHS Foundation Trust, Sutton, UK.
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MeSH Terms
Arm* / radionuclide imaging
Breast Neoplasms / radiotherapy*
Chronic Disease
Endpoint Determination
Hyperbaric Oxygenation*
Lymph Nodes / radiation effects
Lymphedema / etiology*,  radionuclide imaging,  therapy*
Middle Aged
Quality of Life
Risk Factors
Statistics, Nonparametric
Treatment Outcome
Grant Support
//Cancer Research UK; //Department of Health
Erratum In:
Radiother Oncol. 2011 Feb;98(2):285

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