
Hyperbaric oxygen therapy (HBOT) appears effective at reducing pain and fibrosis in women with late local toxic effects related to irradiated breast cancer, according to a study published in JAMA Oncology.
In this hospital-based, pragmatic, 2-arm, randomized, clinical trial, researchers assessed 189 women with moderate or severe breast, chest wall, and/or shoulder pain in combination with mild, moderate, or severe edema, fibrosis, or movement restriction 12 months or longer following breast irradiation. Patients in the population of interest were given 30 to 40 HBOT sessions over a duration of 6 to 8 consecutive weeks.
The study’s primary end point was breast, chest wall, and/or shoulder pain 6 months postrandomization measured by the European Organization for Research and Treatment of Cancer QLQ-BR23 questionnaire. Secondary end points included patient-reported fibrosis, edema, movement restriction, and overall quality of life. Data were assessed according to intention-to-treat (ITT) and complier average causal effect (CACE) principles.
In ITT, moderate or severe pain at follow-up was reported in 50% of patients in the intervention arm and 62% in the control arm (odds ratio, 0.63; 95% CI, 0.32-1.23; P=.18). In CACE, the proportion of women reporting moderate or severe pain at follow-up was 32% among those completing HBOT and 75% (9.7 of 12.9) among control participants expected to complete HBOT if offered. In ITT, moderate or severe fibrosis was reported by 33% in the intervention arm compared with 51% in the control arm.
The researchers concluded that “offering HBOT to women with late local toxic effects was not effective for reducing pain but was effective for reducing fibrosis. In the subgroup of women who completed HBOT, a significant reduction in pain and fibrosis was observed.”