NCT07823660 Cardio-Oncology Rehabilitation in Breast Cancer Patients Undergoing Chemotherapy
| NCT ID | NCT07823660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-12-01 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Rosane M Nery, PhD
PRINCIPAL INVESTIGATOR
Hospital de Clinicas de Porto Alegre
Frequently Asked Questions
Who can join the NCT07823660 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07823660 currently recruiting?
Yes, NCT07823660 is actively recruiting participants. Contact the research team at rnery@hcpa.edu.br for enrollment information.
Where is the NCT07823660 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT07823660 clinical trial?
NCT07823660 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Rosane M Nery, PhD at Hospital de Clinicas de Porto Alegre. The trial plans to enroll 30 participants.
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