Rationale and design of a CArdiac Rehabilitation program on the Prevention of CardioTOXicity in Breast Cancer patients undergoing treatment with anthracyclines and/or trastuzumab (CARPTOX-BC) trial: a randomized, active control group, open-label trial.
This record reports the design of a 284-participant randomized, open-label trial comparing structured supervised exercise with exercise recommendations for prevention of treatment-related cardiac dysfunction in adult women receiving anthracyclines and/or trastuzumab for stage I–III breast cancer.
Open original publication →What the AI sees
This record reports the design of a 284-participant randomized, open-label trial comparing structured supervised exercise with exercise recommendations for prevention of treatment-related cardiac dysfunction in adult women receiving anthracyclines and/or trastuzumab for stage I–III breast cancer.
Research significance
The planned trial will test whether structured aerobic and resistance exercise reduces biomarker- or imaging-defined cardiac dysfunction relative to exercise advice alone; any preventive benefit, quality-of-life improvement, or applicability to pediatric oncology remains hypothetical because no results are reported and eligibility begins at age 18.
Source abstract
BACKGROUND: Breast cancer (BC) remains a leading cause of cancer-related deaths among women. Administration of anthracyclines and/or anti-human epidermal growth factor receptor-2 (HER2) antibodies has been associated with chemotherapy-induced cardiotoxicity. Cardio-oncology rehabilitation programs aim to mitigate these outcomes. However, their preventive role in cancer therapy-related cardiac dysfunction (CTRCD) remains uncertain. OBJECTIVES: To evaluate the effectiveness of a structured exercise program compared with only exercise recommendation in preventing CTRCD, defined by the 2022 European Society of Cardiology criteria, as a left ventricular ejection fraction above 50%, with a relative decrease in global longitudinal strain exceeding 15% from baseline and/or a newly detected elevation in cardiac troponin I or T or natriuretic peptides. Secondary outcomes include the impact on systolic and diastolic echocardiographic parameters, cardiometabolic biomarkers, quality of life, and exploring the role of traditional cardiovascular risk factors in CTRCD onset. METHODS: CARPTOX-BC is a randomized, open-label clinical trial with an active control group. Women aged 18-70 years with stage I-III BC scheduled for neoadjuvant or adjuvant therapy with anthracyclines and/or trastuzumab will be eligible. The intervention includes three supervised out of five weekly aerobic and resistance exercise. A total of 284 participants will be randomized 1:1 to intervention or control arms. RESULTS: Results will be disclosed at completion. CONCLUSIONS: We expect a structured exercise program may reduce the incidence of CTRCD associated with anthracycline and/or HER2 antibody and provide a potential non-pharmacological therapy that could also enhance cardiometabolic markers and quality of life among this population. TRIAL REGISTRATION: NCT06881940 (registered March 18th, 2025).