Exercise-based Cardiac Rehabilitation for the Prevention of Breast Cancer Chemotherapy-induced Cardiotoxicity (ONCORE)

Hospital Clinico Universitario de Santiago

Status

Completed

Conditions

Cardiotoxicity

Cardiac Rehabilitation

Treatments

Other: Cardiac rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03964142

PI17/01687

Details and patient eligibility

About

This project aims to determine whether a comprehensive cardiac rehabilitation program including supervised exercise training is able to prevent cardiotoxicity during treatment with anthracyclines and / or anti-HER-2 antibodies in women with breast cancer. Participants will be randomly allocated to cardiac rehabilitation (intervention group) or conventional management with physical exercise recommendation (control group).

Full description

Cardiovascular toxicity caused by chemotherapy is the leading cause of death in patients who survive cancer. Physical exercise during chemotherapy has shown to improve quality of life and decrease the risk of death. The objective of this project is to determine whether an intervention through a comprehensive cardiac rehabilitation program including supervised physical exercise is able to prevent anthracyclines and / or anti-HER-2 antibodies-induced cardiotoxicity in women with breast cancer.

For this purpose, the investigators intend to conduct a randomized controlled study including female patients managed under the same cardiotoxicity prevention protocol (clinical, laboratory and echocardiographic follow-up assessment). Patients will be randomized to a non-pharmacological intervention (participation in a multidisciplinary cardiac rehabilitation program with supervised exercise training) or control (conventional management and physical activity recommendation)*.

The investigators hypothesize that a cardiac rehabilitation program may limit chemotherapy-induced cardiotoxicity in women with breast cancer, improve cardiac remodeling assessed by echocardiography and enhance their global cardiovascular risk profile to a greater extent, compared to control group.

* OF NOTE: Due to the COVID-19 pandemics, several modifications to the original protocol were introduced for safety reasons or motivated by the health situation, namely:

Intervention: Change from centre-based to telematic supervised exercise training sessions provided within the cardiac rehabilitation program (intervention group)
Secondary outcome 4: Change in functional capacity assessed by conventional ergometry or cardiopulmonary exercise test OR the 6-minute walking test (metabolic equivalents: METs or peak oxygen consumption: VO2)
Recruiting centres: One centre (Hospital Universitari Vall d'Hebron) withdrew from the study due to the impossibility of assuming its execution.

Enrollment

122 patients

Sex

Female

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

First diagnosis of breast cancer at early stages (I, II, III)
Treatment with anthracyclines and / or anti-HER-2 antibodies (trastuzumab and / or pertuzumab)
Possibility of completing a cardiac rehabilitation program (centre-based or telematic) and programmed visits.
Providing written informed consent.

Exclusion criteria

Patients with previous history of heart disease or heart failure.
Left ventricular dysfunction (left ventricular ejection fraction <53%) at baseline.
Metastatic disease.
Patients carrying an implantable cardioverter defibrillator.
Patients with physical or mental limitation to carry out an exercise program.