Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer

Abstract

a b s t r a c tBackground: 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 P15% 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% .5%) in the control group and 133.5% 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. Ó

A Single Blinded Randomized Controlled Clinical Trial on the Efficacy of Ozone Therapy on Breast Cancer-Related Lymphedema

“…Moreover, causes reduction of scar tissues surrounding existing lymphatic obstruction leading to reduction of tissue thickness as well as limb volume (Marx, 1994;Teas et al, 2004;Gothard et al, 2010). However, it is not currently clear how these relate to the clinical effects in humans, as this study did not investigated the effect of ozone on lymphatic dynamic and constituent of edematous tissue.…”

“…However, oxygen as adjuvant modalities has been used in form of hyperbaric therapy for treatment of breast cancer lymphedema (Teas et al, 2004;Gothard et al, 2010;Gothard, Stanton, & MacLaren, 2004). Those authors suggest that hyperbaric oxygen therapy for women with BCRL might be beneficial for reduction of lymphedema, particularly of the hand.…”

“…The use of oxygen might stimulate the growth of new lymphatic channels and reduction of the scar tissues surrounding existing lymphatic channels leading to reduction of limb volume (Teas et al, 2004;Gothard et al, 2010). Ozone is a naturally-occurring configuration of three oxygen atoms best known for its protective role in the earth's ecological harmony, possesses unique properties, which are being defined and applied to biological systems as well as to clinical practice.…”

Hyperbaric Oxygen Therapy and Quality of Life: A Systematic Review

“…HBOT is mostly performed in developed countries, such as USA and UK. According to SF-36 instrument, HBOT improves vitality, physical function, body pain, total health perceptions, mental health and physical, emotional, and social role functioning in patients with troublesome diseases (15,17,19,21,27).…”

“…Perhaps, the type of questionnaires (EORTC QLQ-C30) was inappropriate or sample size was small, according to authors' description (20). Lone Gothard in 2010 did not find good evidence for HBOT in the treatment of arm lymphedema following breast cancer surgery and its adjuvant radiotherapy in early stages (19). HBOT cannot improve QOL in these patients.…”