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Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Treatment With Anthracyclines and/or Trastuzumab
Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
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.
Official title: Rationale and Design of a Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Treatment With Anthracyclines and/or Trastuzumab: A Randomized, Active Control Group, Open-Label Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
284
Start Date
2025-04-01
Completion Date
2029-12-01
Last Updated
2025-03-18
Healthy Volunteers
No
Interventions
Rehabilitation Program
Three of the five weekly sessions will take place at the gym in the Functional Unit of Breast Tumors at INCAN, under the supervision of Physical and Sports Medicine specialists and three physical therapists. These sessions allow for personalized feedback, enabling participants to confidently perform prescribed aerobic exercises at home on the remaining two days. Each session starts with a 10- to 15-minute warm-up focused on joint mobility. Aerobic training is conducted at moderate intensity (40-59% VO2max or heart rate reserve), monitored with a Polar® FT1 device. Intensity is periodically adjusted based on the Borg Rating of Perceived Exertion and the talk test. Over 4-6 weeks, session duration will gradually increase to 90 minutes per week, remaining consistent thereafter. Following aerobic training, resistance exercises targeting major muscle groups are performed using gym machines and dumbbells. The program includes seven exercises, progressively increasing load over 3-4 weeks.
No Rehabilitation Program
The control group will continue standard oncological treatment in addition to general recommendations regarding diet and physical activity, but without a structured exercise protocol.
Locations (2)
Instituto Nacional de Cancerología (INCAN)
Mexico City, Mexico City, Mexico
National Institute of Cancerology (INCAN)
Mexico City, Mexico City, Mexico