Breast cancer is the most prevalent malignancy among women in Brazil, and Porto Alegre (Rio Grande do Sul) has one of the highest incidence rates in women under 50, with 165.5 cases per 100,000 women aged 40-49. Advances in cancer biology, treatment, and supportive care have improved outcomes, leading to increased survivorship. Regular physical exercise has been shown to be an effective strategy in both the prevention and management of breast cancer, and during chemotherapy, physical activity may reduce fatigue, improve quality of life, and increase cardiorespiratory fitness.
This randomized clinical trial will enroll women diagnosed with breast cancer indicated for neoadjuvant or adjuvant chemotherapy. The study aims to characterize the clinical profile of these patients with respect to cardiovascular and functional effects of chemotherapy, and to evaluate an integrated cardio-oncology rehabilitation approach.
The investigators expect to identify the clinical profile of breast cancer patients undergoing chemotherapy and establish associations with the study variables, as well as to assess the effect of a standardized exercise program on the cardiovascular and musculoskeletal systems and quality of life. Based on these results, the study aims to propose a complementary rehabilitation program, to be offered within the public health system, alongside pharmacological treatment during and after completion of the chemotherapy cycle.
Diagnosis of breast cancer
Indicated for chemotherapy treatment
Cardiovascularly stable
Cleared for physical exercise
Any decompensated disease that would compromise the ability to perform the training sessions
Prior diagnosis of ischemic heart disease
Prior diagnosis of valvular heart disease
Prior diagnosis of cardiac arrhythmias
Parallel
Cardio-Oncology Exercise Rehabilitation Program
BehavioralStructured, individualized exercise training sessions held twice weekly at HCPA's Physical Rehabilitation Service (SFR), aimed at mitigating chemotherapy-related cardiovascular and functional impairment in breast cancer patients.
Change in Left Ventricular Ejection Fraction (LVEF)
Left ventricular systolic function assessed by transthoracic echocardiography with strain analysis
Incidence of Cardiotoxicity
Development of cancer therapy-related cardiac dysfunction, including asymptomatic/subclinical cases, defined by relative decline in global longitudinal strain (GLS) on echocardiography.
Change in Electrocardiographic Abnormalities and Arrhythmias
ECG findings assessed as part of the echocardiographic evaluation. The ECG will be assessed for the following parameters: heart rate, cardiac rhythm (to identify arrhythmias), PR interval, QRS complex duration and morphology, QT/QTc interval, and ST-segment/T-wave changes.
Change in Resting Blood Pressure
Measured before cardiopulmonary exercise testing (CPET)
Change in Troponin
Blood biomarker (troponin)
Change in BNP/NT-proBNP
Blood biomarker (BNP/NT-proBNP)
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Blood biomarker (hs-CRP)
Change in TNF-alpha
TNF-alpha
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