Loading clinical trials...
Loading clinical trials...
The CARE-BREAST study is a randomized, controlled clinical trial designed to evaluate the cardioprotective effects of a supervised exercise program in breast cancer survivors. Many life-saving breast cancer treatments, such as anthracyclines and targeted therapies like trastuzumab, are known to be cardiotoxic, potentially causing long-term damage to the heart and a significant decline in cardiorrespirator fitness. This damage, known as Cancer Therapy-Related Cardiac Dysfunction (CTRCD), can manifest months or even years after treatment ends, with the highest risk occurring during the first year of survivorship. This trial focuses on a critical "recovery window," recruiting women aged 30 to 70 who completed cardiotoxic treatments between six months and one year prior to joining the study. The study operates on the primary hypothesis that breast cancer survivors who complete a 16-week supervised, combined exercise program will show significant improvements in myocardial function-specifically measured through the Left Ventricular Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS)-as well as overall aerobic capacity (VO2max) when compared to a control group. The trial aims to determine if structured exercise can mitigate the subclinical heart damage caused by chemotherapy and improve the patient's physical health and quality of life during the transition to long-term survivorship. Participants are randomly assigned to one of two groups. The intervention group participates in a 16-week program consisting of two weekly supervised sessions at a specialized exercise unit. Each session, lasting between 55 and 85 minutes, includes a combination of strength training and aerobic exercise tailored to each participant's individual fitness level. The control group receives standard educational materials via email regarding healthy lifestyle habits and exercise guidelines for cancer survivors but does not participate in the supervised training sessions. To measure the study's impact, all participants undergo comprehensive medical evaluations before and after the 16-week period, including heart imaging via echocardiogram, blood tests to check for cardiac biomarkers like troponin, and a maximal exercise test to assess lung and heart capacity. By comparing these results between the two groups, the research team hopes to generate high-quality evidence that can be used to establish specific exercise prescriptions as a standard part of follow-up care for breast cancer survivors, ultimately helping to protect their heart health and improve their long-term survival outcomes.
Age
18 - 70 years
Sex
FEMALE
Healthy Volunteers
No
University of Castilla-La Mancha (PAFS Research Group)
Toledo, Toledo, Spain
Start Date
September 1, 2026
Primary Completion Date
August 1, 2027
Completion Date
December 1, 2027
Last Updated
February 12, 2026
44
ESTIMATED participants
Control
BEHAVIORAL
Exercise
BEHAVIORAL
Lead Sponsor
University of Castilla-La Mancha
NCT04235764
NCT07061964
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00026884