Impact of physical exercise on cardiotoxicity and cardiac health outcomes in women with breast cancer undergoing anthracycline-containing chemotherapy: a study protocol for a randomized controlled trial
Bibliographic record
Abstract
Abstract 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. Keywords: Breast cancer, cardiotoxicity, cardiac healthcare, supervised exercise, supportive cancer care.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.030 | 0.027 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.012 | 0.006 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.009 | 0.005 |
| Insufficient payload (model declined to judge) | 0.039 | 0.007 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".