Safety and Feasibility of a Multimodal Physiotherapeutic Care Protocol with Vascular Photobiomodulation in Women with Breast Cancer: Randomized Pilot Study

Abstract

Introduction: Breast cancer and its antineoplastic treatment are associated with physical and functional adverse events, requiring safe supportive care strategies. Multimodal physiotherapy protocols have been used for this purpose, and vascular photobiomodulation (VPBM) has emerged as a potentially adjunctive resource. Objective: To evaluate the clinical safety, feasibility, and acceptability of a multimodal physiotherapy protocol including VPBM, compared with a placebo application. Method: This pilot randomized, double-blind, placebo-controlled clinical trial with a parallel design allocated participants to either an intervention or placebo group. Participants underwent ten sessions over five weeks, including transdermal application of VPBM over the left radial artery. Outcomes included patient-reported adverse events, tolerability, adherence, and satisfaction. Pain, heaviness sensation, and perceived edema were assessed as exploratory secondary outcomes. Results: Twelve women initiated the protocol, with 100% adherence. No serious adverse events were observed. Across 120 applications, eight episodes of mild, transient, and self-limited discomfort were reported, more frequently in the intervention group, without requiring interruption. An intragroup reduction in the musculoskeletal pain domain was observed (p=0.035), with no differences between groups; this finding was interpreted as exploratory. Acceptability was high, with elevated satisfaction levels in both groups. Conclusion: The multimodal physiotherapy protocol including VPBM was feasible, well tolerated, and well accepted in women undergoing treatment for breast cancer. Due to the pilot nature and multimodal design, no specific effects can be attributed to VPBM, reinforcing the need for confirmatory studies.