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

Objective: To evaluate if combining a prospective surveillance model (PSM) with a supervised multimodal exercise program prevents breast cancer-related lymphedema (BCRL) and its effect 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 (N=116; age ≥18y) 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 body mass index 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. Conclusions: 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.