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

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 Overview

• Status: Recruiting
• Conditions: Early-stage Breast Cancer
• Intervention / Treatment: Other: Acute Exercise

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Alonso; Phone Number: + 34 678942096; Email: maria.alonsod@alumnos.upm.es

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • "Ramón y Cajal" Hospital
    • Contact: María Alonso; Phone Number: +34 678942096; Email: maria.alonsod@alumnos.upm.es
    • Principal Investigator: Maria Fernandez Abad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control; 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?

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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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.
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.
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.
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).

Collaborators and Investigators

• Sponsor: Technical University of Madrid

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Breast Cancer; Cardiotoxicity; Doxorubicin; anthracyclines
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: DATOS-20220624-ASJF-Efecto car

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No