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NOT YET RECRUITING
NCT06881940
NA

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

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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