Exercise Program During Preoperative Chemotherapy to Improve Breast Cancer Treatment Outcomes The Neo-ACT Randomized Trial

What this Trial Is About

Researchers are investigating whether adding physical exercise during neoadjuvant chemotherapy NACT can improve outcomes for patients with primary invasive breast cancer. This trial focuses on whether exercise can increase the rate of pathological complete response pCR, meaning no invasive tumor remains after chemotherapy. Secondary goals include evaluating cancer burden after treatment, tumor response through imaging, quality of life, physical activity levels, muscle strength, fitness, cognitive effects, treatment completion, and long-term sick leave. The study also explores how exercise may influence anti-tumor mechanisms. Participants will be randomly assigned to one of two groups usual care with routine information about physical activity or a supervised exercise program during chemotherapy. The exercise group will engage in two 60-minute sessions weekly of high-intensity interval and strength training, supported by a personalized mobile app and local physiotherapists. The program starts with a moderate warm-up and is tailored to each patients fitness and perceived exertion, continuing from the start of chemotherapy until surgery, about five months. Throughout the study, participants will be carefully monitored with questionnaires, physical tests, and device-based activity tracking. Assessments include quality of life surveys, physical activity reports, muscle strength tests, cognitive function scans, fitness evaluations, tumor imaging, chemotherapy completion rates, and sick leave data. The primary outcome, pathological complete response, is assessed around 5-6 months after starting chemotherapy. Follow-up and data collection continue for up to two years to evaluate long-term effects and safety.

Physical Exercise During Preoperative Chemotherapy for Breast Cancer