Gothard L, Haviland J, Bryson P, Laden G, Glover M, Harrison S, Woods M, Cook G, Peckitt C, Pearson A, Somaiah N, Stanton A, Mortimer P, Yarnold J, et al.
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncol.... Date of publication 2010 Oct 1;volume 97(1):101-7.
1. Radiother Oncol. 2010 Oct;97(1):101-7. doi: 10.1016/j.radonc.2010.04.026. Epub
2010 May 31.
Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic
arm lymphoedema after radiotherapy for cancer.
Gothard L(1), Haviland J, Bryson P, Laden G, Glover M, Harrison S, Woods M, Cook
G, Peckitt C, Pearson A, Somaiah N, Stanton A, Mortimer P, Yarnold J.
Author information:
(1)Department of Radiotherapy, The Royal Marsden NHS Foundation Trust, Sutton,
UK.
Erratum in
Radiother Oncol. 2011 Feb;98(2):285.
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.
Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.
DOI: 10.1016/j.radonc.2010.04.026
PMID: 20605648 [Indexed for MEDLINE]