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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2023-01-01

Brief Summary

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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).

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Detailed Description

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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:

1. Intervention: Change from centre-based to telematic supervised exercise training sessions provided within the cardiac rehabilitation program (intervention group)
2. 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)
3. Recruiting centres: One centre (Hospital Universitari Vall d'Hebron) withdrew from the study due to the impossibility of assuming its execution.

Conditions

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Cardiotoxicity Cardiac Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cardiac Rehabilitation

Patients enrolled in the integrated exercise-based cardiac rehabilitation program (centre-based or telematic)

Group Type EXPERIMENTAL

Cardiac rehabilitation

Intervention Type OTHER

Integrated cardiac rehabilitation program that includes supervised exercise training\*.

\* Due to the COVID-19 pandemic, supervised physical exercise training had to be conducted telematically (through live guided training sessions conducted online, with the same design, frequency, and dosage of exercise).

Conventional management

Patients with conventional management and physical activity recommendation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cardiac rehabilitation

Integrated cardiac rehabilitation program that includes supervised exercise training\*.

\* Due to the COVID-19 pandemic, supervised physical exercise training had to be conducted telematically (through live guided training sessions conducted online, with the same design, frequency, and dosage of exercise).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No