Clinical trial · Interventional
Cardio-Oncology Rehabilitation in Breast Cancer Patients Undergoing Chemotherapy
Effect of Chemotherapy Treatment on the Cardiovascular System: Clinical Profile of Patients Diagnosed With Breast Cancer and an Integrated Cardio-Oncology Rehabilitation Approach. A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardio-Oncology Exercise Rehabilitation Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise Training Group
- description
- Participants will undergo a cardio-oncology rehabilitation program with supervised exercise training sessions twice weekly at HCPA's Physical Rehabilitation Service (SFR). Assessments will be performed at baseline and at 3 and 6 months.
- interventionNames
- Behavioral: Cardio-Oncology Exercise Rehabilitation Program
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Participants will receive general health and nutritional guidance at the baseline assessment and will maintain usual care, without a structured exercise program. Assessments will be performed at baseline and at 3 and 6 months, following the same schedule as the intervention group.
Primary outcomes (10)
- measure
- Change in Left Ventricular Ejection Fraction (LVEF)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (23)
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