title: Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer.
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.
  
  
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiotherapy, The Royal Marsden NHS Foundation Trust, Sutton, UK.
authors.forename: Lone
authors.initials: L
authors.lastname: Gothard
authors.forename: Joanne
authors.initials: J
authors.lastname: Haviland
authors.forename: Phil
authors.initials: P
authors.lastname: Bryson
authors.forename: Gerard
authors.initials: G
authors.lastname: Laden
authors.forename: Mark
authors.initials: M
authors.lastname: Glover
authors.forename: Steven
authors.initials: S
authors.lastname: Harrison
authors.forename: Mary
authors.initials: M
authors.lastname: Woods
authors.forename: Gary
authors.initials: G
authors.lastname: Cook
authors.forename: Clare
authors.initials: C
authors.lastname: Peckitt
authors.forename: Ann
authors.initials: A
authors.lastname: Pearson
authors.forename: Navita
authors.initials: N
authors.lastname: Somaiah
authors.forename: Anthony
authors.initials: A
authors.lastname: Stanton
authors.forename: Peter
authors.initials: P
authors.lastname: Mortimer
authors.forename: John
authors.initials: J
authors.lastname: Yarnold
mesh_terms: D001132:Arm / Q000000981:diagnostic imaging; D001943:Breast Neoplasms / Q000532:radiotherapy*; D002908:Chronic Disease; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006931:Hyperbaric Oxygenation; D008198:Lymph Nodes / Q000528:radiation effects; D008209:Lymphedema / Q000000981:diagnostic imaging / Q000209:etiology* / Q000628:therapy*; D008875:Middle Aged; D011788:Quality of Life; D011877:Radionuclide Imaging; D012307:Risk Factors; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome