Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Unde… (NCT06881940) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Treatment With Anthracyclines and/or Trastuzumab
Mexico284 participantsStarted 2025-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion Criteria:
* 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.
* Patients will provide informed written consent to participate in the study. To uphold ethical research principles and ensure the protection of participants' rights, all patients m…
What they're measuring
1
Incidence of cardiac dysfunction or heart failure as a manifestation of cardiovascular toxicity in the intervention group and control group
Timeframe: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Trial details
NCT IDNCT06881940
SponsorInstituto Nacional de Cardiologia Ignacio Chavez