Non-randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema and tissue fibrosis after radiotherapy for early breast cancer

Department of Radiotherapy, Royal Marsden NHS Trust, Sutton, Surrey SM2 5PT, UK.
Radiotherapy and Oncology (Impact Factor: 4.86). 03/2004; 70(3):217-24. DOI: 10.1016/S0167-8140(03)00235-4
Source: PubMed

ABSTRACT Radiation-induced arm lymphoedema is a common and distressing complication of curative treatment for early breast cancer. Hyperbaric oxygen (HBO(2)) therapy promotes healing in bone rendered ischaemic by radiotherapy, and may help some soft-tissue injuries too, but is untested in arm lymphoedema.
Twenty-one eligible research volunteers with a minimum 30% increase in arm volume in the years after axillary/supraclavicular radiotherapy (axillary surgery in 18/21 cases) were treated with HBO(2). The volunteers breathed 100% oxygen at 2.4 ATA for 100 min in a multiplace hyperbaric chamber on 30 occasions over a period of 6 weeks. The volume of the ipsilateral limb, measured opto-electronically by a perometer and expressed as a percentage of contralateral limb volume, was selected as the primary endpoint. A secondary endpoint was local lymph drainage expressed as fractional removal rate of radioisotopic tracer, measured using lymphoscintigraphy.
Three out of 19 evaluable patients experienced >20% reduction in arm volume at 12 months. Six out of 13 evaluable patients experienced a >25% improvement in (99)Tc-nanocolloid clearance rate from the ipsilateral forearm measured by quantitative lymphoscintigraphy at 12 months. Overall, there was a statistically significant, but clinically modest, reduction in ipsilateral arm volume at 12 months follow-up compared with baseline (P = 0.005). The mean percentage reduction in arm volume from baseline at 12 months was 7.51. Moderate or marked lessening of induration in the irradiated breast, pectoral fold and/or supraclavicular fossa was recorded clinically in 8/15 evaluable patients. Twelve out of 19 evaluable patients volunteered that their arms felt softer, and six reported improvements in shoulder mobility at 12 months. No significant improvements were noted in patient self-assessments of quality of life.
Interpretation is limited by the absence of a control group. However, measurement of limb volume by perometry is reportedly reliable, and lymphoscintigraphy is assumed to be operator-independent. Taking all data into account, there is sufficient evidence to justify a double-blind randomised controlled trial of hyperbaric oxygen in this group of patients.

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Available from: Emma Hall, Jul 28, 2015
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    • "Hyperbaric oxygen chambers have been used in wound-healing for some time now and this treatment is still being studied for its effectiveness for LE treatment. A phase II clinical trial (Gothard et al., 2004) did reveal a statistically significant reduction in limb volume following hyperbaric treatment in patients who had received radiotherapy for breast cancer. This group of patients (N = 21) was given hyperbaric treatment 30 times over 6 weeks. "
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    • "The effects of hyperbaric oxygen (HBO) therapy offer the strongest clinical evidence in support of healing responses in previously irradiated tissues, including preliminary evidence of a volume response to HBO in radiation-induced arm lymphoedema [19; 18; 13]. In a nonrandomised phase II study of 21 patients, a mean 8% reduction in total arm volume at 12 months was recorded using the same techniques as those used in the present study (p = 0.005) [13]. Optical volume measurements using a perometer are highly reproducible [12; 21], as the placebo arm of the present study confirms (Tables 3 & 4). "
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    • "Biological and biophysical RIF assessment Assessment of the severity of tissue fibrosis using clinically based rating scales and quantitative biophysics analysis is not easy. The recording of superficial RIF manifestations can be completed by photograph archiving and measurements such as limb circumference [73] "
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