Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Conditions
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Early-stage Breast Cancer

Intervention / Treatment
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* Other: Acute Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines) 24-48 hours prior to each cycle of anthracyclines. | Other: Acute Exercise<br>* Patients will perform an acute bout of exercise (different types of exercise for each cycle of anthracyclines, as aerobic exercise, strength training or combined training) 24-48 hours prior to each cycle of anthracyclines.<br>|
| No Intervention: Control<br>Patients will receive standard treatment for each type of tumor proposed by the hospital. This group of patients will be provided with the international recommendations on physical exercise for cancer patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP | Biomarker of cardiac injury value in blood tests | 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Troponin I | Biomarker of cardiac injury value in blood tests | 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment | 
| Blood Pressure | Resting blood pressure assesed by sphyngomanometer | 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 | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Exercise, Doxorubicin, anthracyclines, Cardiotoxicity