Cardio-Oncology Rehabilitation in Breast Cancer Patients Undergoing Chemotherapy
NCT07823660
Summary
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.
Eligibility
Inclusion Criteria: 1. Diagnosis of breast cancer 2. Indicated for chemotherapy treatment 3. Cardiovascularly stable 4. Cleared for physical exercise 5. Willing to participate in the study 6. Physically able to perform the assessments and training sessions Exclusion Criteria: 1. Any decompensated disease that would compromise the ability to perform the training sessions 2. Prior diagnosis of ischemic heart disease 3. Prior diagnosis of valvular heart disease 4. Prior diagnosis of cardiac arrhythmias 5. Myocarditis within the past 6 months 6. History of heart failure 7. LVEF \<55% prior to initiation of chemotherapy 8. Musculoskeletal disorders that limit the ability to perform the exercises 9. Diagnosis of peripheral arterial occlusive disease within the past 6 months 10. Ankle-brachial index \<0.4 11. Cognitive impairment that would compromise understanding of study procedures or participation
Conditions2
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NCT07823660