Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life in Early HER2-Positive and Triple-Negative Breast Cancer Patients

The goal of this trial is to learn if a home-based exercise program (intervention) reduces fatigue and improves quality of life in adult patients with early breast cancer who are proposed for preoperative chemotherapy. Conducted at Centro Hospitalar Universitário de Santo António, Porto, Portugal. It compares a structured exercise program prescribed by the physical and rehabilitation medicine team to routine counseling for physical activity by the medical oncologist. All participants will: 1. Visit the hospital 3 times for physical assessments, at beginning of chemotherapy (T0), at 3-months (T1) and 1 month after surgery (T2) 2. Reply to questionnaires of fatigue and quality of life, at T0, T1 and T2 3. Adhere to routine medical oncology visits, treatments and exams Participants of the intervention-arm will additionally: 1. Receive a exercise book, with exercise instructions and calendar 2. Have two in-person lessons about the exercise program 3. Visit the hospital 1 additional time, to have the second lesson 4. Wear a sport bracelet while exercising, to monitor heart rate Recruitment began in April 2024, with results to be shared in medical publications and conferences.

NCT Number	NCT06782698
Lead Sponsor	Centro Hospitalar Universitário de Santo António Collaborators: Universidade do Porto
Conditions	Triple Negative Breast Cancer (TNBC), HER2-Positive Breast Cancer, Early Breast Cancer, Cancer-related Fatigue, Quality of Life (QOL)
Enrollment	50 participants
Start Date	2024-04-01
Primary Completion	2026-03 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-01-20