Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Early-stage Breast Cancer Clinical Trial

— CardioProtEx  

Official title:

Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05467111
• Other study ID #: DATOS-20220624-ASJF-Efecto car
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Technical University of Madrid
• Contact: María Alonso
• Phone: + 34 678942096
• Email: maria.alonsod[@]alumnos.upm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-stage Breast Cancer

Intervention

Other:
• Acute Exercise
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.

Locations

Country	Name	City	State
Spain	"Ramón y Cajal" Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Quality of Life	Assesed using the validated EORTC-QLQ-C30 quality of life questionnaire	Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
Other	Fatigue	Assesed using the validated Functional Assessment of Cancer Therapy: Fatigue (FACT-F)	Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
Other	Physical Activity	Assesed using the validated International Physical Activity Questionnaire (IPAQ-SF)	Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
Other	Assessment of functional mobility	Assesed using the Timed Up and Go (TUG) test	0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
Other	Assessment of lower extremity strength and power	Assesed using the Sit to Stand test	0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
Other	Assessment of isometric handgrip	Assesed using the hand grip dynamometer test	0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
Primary	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	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
Secondary	Blood Pressure	Resting blood pressure assesed by sphyngomanometer	24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Secondary	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).