1909TiP - Home-based physical exercise during neoadjuvant treatment for early breast cancer patients (HoPEx-Breast): A pragmatic randomised controlled trial

Background

Breast cancer (BC) accounts for nearly 1:4 cancer diagnoses in females. Systemic therapy (ChT) for early BC, in particular anthracycline-based regimens, often causes fatigue with significant impact on daily life. Physical exercise (PEx) is recommended for improving health-related quality of life (QoL) and cancer-related fatigue. Home-based programs are a promising and feasible tool to achieve that, with previous descriptions of good adherence, efficacy and safety in different settings. We aim to evaluate the impact on patient-reported QoL and fatigue, of a home-based PEx (HoPEx) program as compared with short counselling on physical activity by the medical oncologist, among recently diagnosed HER2 enriched and triple negative (TN) BC patients (pts) of our institution that have been proposed for neoadjuvant (NA) ChT.

Trial design

Pragmatic single-centre randomised controlled trial of HoPEx program, involving recently diagnosed pts with HER-2 enriched or TN BC who undergo NA ChT. Pts will be randomly assigned, in a 1:1 ratio, to HoPEx intervention or short counselling. The intervention will consist of 2 supervised explanatory sessions, followed by a weekly schedule of 2 sessions of resistance exercise and 3 periods of aerobic training, in their home environment until the end of NA ChT, according to the HoPEx instructions manual. Recruitment started on March 26, 2024, and is expecting to continue until Decembre 2024 or until achieving a sample size of 50 pts. FACIT-Fatigue subscale and EORTC QLQ-c30 and QLQ-Br45 will be used to assess fatigue symptoms and QoL, respectively. Assessments will occur at baseline, 12 weeks after beginning of preoperative ChT (T1) and 1 month after surgery (T2). We will conduct an intention to treat analysis of the change in EORTC QLQ-30 and FACIT-Fatigue scores at T1 and T2. Additionally, we will assess effects in physical activity level, physical capacity, cardiac function, inflammatory and metabolic markers, oncological outcomes, safety, acceptability and costs. Informed consent will be obtained before intervention. Confidentiality of data will be ensured. The study was approved by ethics committee.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.