Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

NCT05467111 | Recruiting

• 1 other identifier: DATOS-20220624-ASJF-Efecto car
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-stage Breast Cancer

Keywords

Breast Cancer; Exercise; Doxorubicin; anthracyclines; Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cardiac Troponin I

  24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment

• Blood Pressure

  24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment

• 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).

Other Outcomes (6)

• Changes in Quality of Life

  Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).

• Fatigue

  Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).

• Physical Activity

  Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).

Study Arms (2)

Exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Acute Exercise OTHER

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.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technical University of Madrid: lead

Study Sites (1)

"Ramón y Cajal" Hospital

Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Cardiotoxicity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

María Alonso

CONTACT

+ 34 678942096; maria.alonsod@alumnos.upm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Physical Activity and Health

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 20, 2022
• Study Start: January 23, 2023
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

ES (1)