Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Technical University of Madrid40 enrolled

Overview

Cardiotoxicity is one of the most significant adverse effects in breast cancer patients treated with anthracyclines (a type of chemotherapy), so we propose to determine whether acute training (i.e., 24h before each chemotherapy session) could reduce the levels of a cardiac biomarker which measures muscle damage (NT-proBNP). Given the fact NT-proBNP attenuation has been observed with one session performed 24h before the first treatment, we propose to verify these findings in each cycle of doxorubicin analyzing how each type of exercise (aerobic, strength or combined aerobic + strength) may impact on anthracycline-induced cardiotoxicity, since this observation may be relevant considering the feasibility and low cost this implementation would represent in clinical practice.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Early-stage Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Woman with non-metastatic breast cancer not previously treated. * Scheduled to receive neoadjuvant doxorubicin chemotherapy. * Receive the oncologist´s approval for the practice of exercise. * Acceptance of randomization. * To sign an informed consent form before starting any measurement or procedure related to the project. Exclusion Criteria: * Patients who receive initial surgery and who are not going to receive neoadjuvant treatment. * Contraindications to perform stress tests following the recommendations of the American Thoracic Society. * Pre-existing cardiovascular disease. * Body mass index (BMI) \> 35 kg/m2. * Diabetes mellitus. * Renal disease. * Severe anemia. * Pregnacy. * Current smoking status.

Outcomes

Primary Outcomes

NT-proBNP

Biomarker of cardiac injury value in blood tests

Time frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment

Secondary Outcomes

Cardiac Troponin I

Biomarker of cardiac injury value in blood tests

Time frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment

Blood Pressure

Resting blood pressure assesed by sphyngomanometer

Time frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment

Left Ventricular Ejection Fraction (LVEF)

Change in left ventricular systolic function quantified by transthoracic echocardiography

Time frame: 0-14 days prior to the first treatment ( according to the usual clinical practice) and in the follow-up period (6 months after completion of the anthracycline treatment).

Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts