Cardiotoxicity Assessment and Reduction Through Exercise in BREAST Cancer

NCT07405385 | Not Yet Recruiting

• 1 other identifier: 2024-UNIVERS-12844
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Breast Cancer; Neoplasm; Cardiotoxicity

Outcome Measures

Primary Outcomes (3)

• Change in Global Longitudinal Strain

  Measurement of myocardial deformation using transthoracic echocardiography to detect subclinical alterations in cardiac function.

  7 months

• Change in LVEF

  Assessment of the volume of blood pumped out of the left ventricle with each contraction, measured via the biplane Simpson's method and 3D echocardiography.

  7 months

• Changes in Cardiorespiratory Fitness

  Assessment of cardiorespiratory capacity determined through a maximal cardiopulmonary exercise test (stress test) on a cycle ergometer

  7 months

Secondary Outcomes (15)

• Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)

  7 months

• Change in High-sensitivity Cardiac Troponin (hs-cTn)

  7 months

• Change in Lower Body Muscular Strength

  7 months

• Change in Upper-Body Muscular Strength

  7 months

• Change in 6-Minute Walk Test

  7 months

Study Arms (2)

EXERCISE GROUP

EXPERIMENTAL

Behavioral: Exercise

CONTROL GROUP

OTHER

Behavioral: Control

Interventions

Control BEHAVIORAL

Participants assigned to the control group receive standard care typically provided to patients in this phase of recovery. Instead of a supervised exercise program, these individuals are sent educational materials via email. This material consists of a video and official documents containing basic guidelines and recommendations for a healthy lifestyle, based on standards from the World Health Organization (WHO) and the American College of Sports Medicine (ACSM) for cancer survivors. The documents provide general instructions on physical activity, reducing sedentary behavior, and maintaining overall health habits. Like the intervention group, participants in the control group undergo all clinical and functional evaluations at the start of the study, after 16 weeks, and during a 3-month follow-up.

CONTROL GROUP

Exercise BEHAVIORAL

The intervention consists of a supervised, in-person, combined exercise program lasting 16 consecutive weeks, conducted at a specialized exercise unit. Participants attend two sessions per week, with at least 48 hours of recovery between sessions, and each session lasts between 55 and 85 minutes. The program follows a "combined" methodology, meaning every session integrates both resistance (strength) and aerobic training. To ensure safety and precision, sessions are led by a graduate in Physical Activity and Sport Sciences with specialized training in oncology, and participants work in small groups of 6 to 8 people. Each session is structured into four distinct parts: a 10-minute warm-up involving low-to-moderate intensity activity and joint mobility; a resistance training block; an aerobic training block; and a cool-down featuring static stretching for 30-40 seconds per muscle group. The resistance training portion utilizes a "full body" approach.

EXERCISE GROUP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged between 18 and 70 years.
• Confirmed diagnosis of breast cancer in stages I to III.
• Patients who completed treatment with cardiotoxic agents (anthracyclines, trastuzumab, or pertuzumab) between 6 months and 1 year prior to enrollment.
• Residency within a distance of less than 40 km from the Hospital Universitario de Toledo.

You may not qualify if:

• Diagnosis of diabetes mellitus with poor glycemic control, defined as an HbA1c value greater than or equal to 8.5%.
• Presence of an acute infectious disease.
• Medical contraindication for the performance of a maximal exercise stress test.
• Medical contraindication for the practice of physical exercise.
• Relative or absolute contraindications for physical exercise according to ACSM (American College of Sports Medicine) guidelines.
• Serious heart or cardiovascular disease, including a history of myocardial infarction, heart failure, or known cardiomyopathy.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

University of Castilla-La Mancha (PAFS Research Group)

Toledo, Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Cardiotoxicity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Susana Aznar Laín

CONTACT

+34 669356600; susana.aznar@uclm.es

Alejandro Jiménez Marín

CONTACT

+34 685414255; alejandro.jimenez@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-01

Locations

ES (1)