Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Not Applicable

Recruiting

• Conditions: Early-stage Breast Cancer
• Interventions: Other: Acute Exercise

• Registration Number: NCT05467111
• Lead Sponsor: Technical University of Madrid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-20
• Study Start: 2023-01-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-04
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Acute Exercise	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.

Primary Outcome Measures

Name	Time	Method
NT-proBNP	24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment	Biomarker of cardiac injury value in blood tests

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment	Resting blood pressure assesed by sphyngomanometer
Cardiac Troponin I	24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment	Biomarker of cardiac injury value in blood tests
Left Ventricular Ejection Fraction (LVEF)	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).	Change in left ventricular systolic function quantified by transthoracic echocardiography

Trial Locations

Locations (1)

"Ramón y Cajal" Hospital; 🇪🇸 Madrid, Spain