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

April 9, 2024 updated by: Alejandro San Juan Ferrer, Technical University of Madrid

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Recruiting
        • "Ramón y Cajal" Hospital
        • Contact:
        • Principal Investigator:
          • Maria Fernandez Abad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
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
Time Frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
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
Time Frame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
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)
Time Frame: 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
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
Time Frame: Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
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
Time Frame: Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
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
Time Frame: 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
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
Time Frame: 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
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
Time Frame: 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
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
Time Frame: Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
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

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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