Cardioprotective Effect of Acute Exercise in Breast Cancer Patients (CardioProtEx)

Technical University of Madrid

Status: Enrolling

Conditions: Early-stage Breast Cancer

Treatments: Other: Acute Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05467111

DATOS-20220624-ASJF-Efecto car

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Exercise

Experimental group

Description:

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.

Treatment:

Other: Acute Exercise

Control

No Intervention group

Description:

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.