Randomized Trial Assessing Prospective Surveillance and Exercise for Preventing Breast Cancer-Related Lymphedema in High-Risk Patients.

Abstract

Objective: to evaluate if combining prospective surveillance model (PSM) with a supervised multimodal exercise program prevents breast cancer-related lymphedema (BCRL) and its impact on the functional capacity and quality of life (QoL) of high-risk breast cancer (BC) patients undergoing treatment.

Design: two-arm parallel superiority randomized controlled trial.

Setting: outpatient physical therapy service in a public hospital.

Participants: 116 adult women (≥18-year-old) diagnosed with stage I-III BC were enrolled. Inclusion criteria included recent surgery and indication for adjuvant chemotherapy. Exclusion criteria were significant arm volume difference, previous cancer, exercise contraindications, and extreme BMI values.

Interventions: participants were randomized into experimental (n=61) or control groups (n=55) in a 1:1 ratio. The experimental group received PSM with a supervised multimodal exercise program for 12 weeks. The control group received PSM alone.

Main outcome measures: arm volume, grip strength, 6-minute walk test, and QoL were blindly assessed at baseline, 3, 6, and 9 months.

Results: the combination of PSM with a supervised multimodal exercise program significantly reduced arm volume and body weight and improved grip strength, functional capacity, and the QoL of patients.

Conclusion: combining PSM and physical exercise reduces arm volume, prevents BCRL, and improves physical performance and QoL in high-risk patients. The combination of PSM and STRONG-B was superior to PSM alone, validating the study's superiority design.