Key result
A structured supervised exercise program is being evaluated for its cardioprotective effects against anthracycline-related cardiotoxicity in women with early breast cancer, with no results available yet as this is a study protocol.
Why the study?
Anthracyclines carry a cumulative risk of cardiotoxicity, and while exercise is proposed as a cardioprotective countermeasure, evidence largely derives from animal studies and requires clinical trials with accurate biomarkers.
RCT (n=86)
Open-label with blinded outcome assessment
Permutated block design with random block sizes (4, 6, 8) and stratification
No
Background: Anthracyclines are chemotherapeutic agents frequently used in breast cancer (BC) treatment. Although improving disease-free and overall survival, the use of anthracyclines is associated with a cumulative risk of cardiac toxicity. Preventive strategies to optimize and balance cardiac health are needed, being exercise proposed as a potential non-pharmacological approach for counteracting of anthracycline-related cardiotoxicity (ARC). Despite most of the data analysing the role of exercise against cardiac toxicity and dysfunction caused by anthracyclines derived from animal studies, human studies claim for more accurate and valuable clinical biomarkers. Moreover, clinical trials in real-world setting and large samples are of pivotal importance. Methods: This protocol describes a two-arm prospective randomized controlled trial that will explore the cardioprotective effect of a structured exercise program against ARC in women with BC. Eighty-six adult women with early BC and with a therapeutic decision to receive anthracycline-containing chemotherapy (ACT) will be randomly assigned (1:1) to an intervention group or to a control group. Patients allocated to the intervention group will perform a 3-weekly supervised exercise program combining resistance and aerobic training with progressive intensity (light-to-vigorous), during the overall ACT. The control group will receive standard BC care. Primary outcomes related to cardiac (dys)function will be circulating N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, resting left ventricular (LV) longitudinal strain, and resting LV ejection fraction. Secondary outcomes will include the assessment of resting blood pressure, resting heart rate (HR), resting HR variability (HRV) and recovery HR. Exploratory outcomes include physical function outcomes, self-reported physical activity level, health related to quality of life and fatigue. Data will be obtained at baseline (t0), after the end of anthracycline-treatment (t1), and three months after t2 (t2). Additionally, NT-proBNP levels will be measured between 1-24 hours prior to each anthracycline-treatment cycle. Discussion: The implementation of the present study design, using novel clinical biomarkers and “between” outcomes’ associations, will help to understand the effectiveness of structured exercise interventions at mitigating ARC, further contributing to the improvement of supportive cancer care. Trial registration: ISRCTN, ISRCTN32617901. Registered on 24 October 2018. Last updated on 11 January 2019, https://doi.org/10.1186/ISRCTN32617901.
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Antunes et al. (2019) conducted an RCT in Early breast cancer (n=86). Supervised exercise program vs. Standard breast cancer care was evaluated on Circulating NT-proBNP levels, resting LV global longitudinal strain, and resting LV ejection fraction. A structured supervised exercise program is being evaluated for its cardioprotective effects against anthracycline-related cardiotoxicity in women with early breast cancer, with no results available yet as this is a study protocol.
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