This study aims to evaluate the effectiveness of a cardiac rehabilitation protocol, incorporating aerobic and resistance exercise, in reducing the incidence of cardiotoxicity in breast cancer patients receiving treatment with anthracyclines and/or trastuzumab through a randomized, active control group, open-label clinical trial.
Women aged between 18 and 70 years will be considered eligible.
Active residents of any municipality within Mexico City and the surrounding metropolitan area will qualify, conditioned that their maximum travel time from their residence to our recruitment center does not exceed three hours using private or public transportation. This criterion is established to ensure adherence to the protocol and availability for participation in the required interventions and assessments throughout the study.
Patients diagnosed with early-stage or locally advanced breast cancer (stages I, II, or III, according to the TNM classification-Tumor, Node, Metastasis) who will undergo treatment with anthracyclines and/or adjuvant/neoadjuvant anti-HER2 therapy will be included. Participants must be scheduled to receive pharmacological treatment, ensuring that the study focuses on a population undergoing specific therapies for breast cancer management.
Candidates must have the capacity, availability, and willingness to participate in an aerobic and resistance exercise program. Participants are required to possess both the physical ability and the willingness to actively engage in a structured exercise program, which includes aerobic and resistance activities essential to the study's objectives.
Metastatic disease: Individuals with medical or imaging evidence of metastasis to any peripheral organ.
Cardiovascular disease: Patients with a self-reported history of cardiovascular conditions, such as heart failure or uncontrolled hypertension, that may limit their ability to safely engage in physical activity. Additionally, those with peripheral arterial disease or valvular heart disease will not be eligible.
Ischemic heart disease: Patients with a history of ischemic heart disease.
Neurological disorders: Individuals with self-reported neurological diseases that significantly impair coordination, balance, or motor control, such as advanced Parkinson's disease, late-stage multiple sclerosis, or paralysis, making physical activity unsafe.
Parallel
Rehabilitation Program
Other interventionThree of the five weekly sessions will take place at the gym in the Functional Unit of Breast Tumors at INCAN, under the supervision of Physical and Sports Medicine specialists and three physical therapists. These sessions allow for personalized feedback, enabling participants to confidently perform prescribed aerobic exercises at home on the remaining two days. Each session starts with a 10- to 15-minute warm-up focused on joint mobility. Aerobic training is conducted at moderate intensity (40-59% VO2max or heart rate reserve), monitored with a Polar® FT1 device. Intensity is periodically adjusted based on the Borg Rating of Perceived Exertion and the talk test. Over 4-6 weeks, session duration will gradually increase to 90 minutes per week, remaining consistent thereafter. Following aerobic training, resistance exercises targeting major muscle groups are performed using gym machines and dumbbells. The program includes seven exercises, progressively increasing load over 3-4 weeks.
No Rehabilitation Program
Other interventionThe control group will continue standard oncological treatment in addition to general recommendations regarding diet and physical activity, but without a structured exercise protocol.
Incidence of cardiac dysfunction or heart failure as a manifestation of cardiovascular toxicity in the intervention group and control group
Calculate the incidence of cardiotoxicity associated with anthracycline and/or trastuzumab treatment of two groups following the 2022 European Society of Cardiology (ESC) definitions for cancer-related therapy cardiac dysfunction (CTRCD). LVEF greater than 50% with a relative GLS decrease exceeding 15% and/or a new rise in cardiac biomarkers. LVEF will be determined using Simpson's biplane method, incorporating apical four- and two-chamber views, while 2D-GLS measurements will be performed via velocity vector imaging. All echocardiographic evaluations will be conducted using a Siemens-Acuson 2000 system by a single expert in echocardiography, with results subsequently verified by a second expert to ensure accuracy and reliability. The classification of symptomatic congestive heart failure encompasses, but is not limited to, the presence of one or more of the following clinical manifestations: moist crackles in the lungs, bilateral anterior tibial edema, or lip cyanosis.
Impact on echocardiographic parameters
This study aims to evaluate cardiac function by examining changes in echocardiographic parameters, including chamber volumes, diameters, diastolic function, right ventricular function, and both biventricular and auricular global longitudinal strain (GLS).
Modification in series of circulating cardiac biomarkers
Classical biomarkers of cardiac injury: C-reactive protein, Troponin I, B-type natriuretic peptide (NT-Pro BNP).
Evaluation of cardiorespiratory performance
The study will investigate modifications in cardiorespiratory fitness by measuring peak oxygen uptake (VO2max) through a cardiopulmonary exercise test (CPET) conducted on a bicycle ergometer with individualized workload adjustments.
Quality of Life Questionnaire: FACT-B
Investigators should evaluate the quality of life of the patient with QOL questionnaire (FACT-B)
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Instituto Nacional de Cardiologia Ignacio Chavez
Lead sponsor
Instituto Nacional de Cancerologia de Mexico
Collaborator
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