Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Sponsor

Technical University of Madrid (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05467111

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early-stage Breast Cancer	Other: Acute Exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cardioprotective Effect of Acute Exercise in Breast Cancer Patients

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
Blood Pressure [24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment]
Resting blood pressure assesed by sphyngomanometer
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

Other Outcome Measures

Quality of Life [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
Fatigue [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)
Physical Activity [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)
Assessment of functional mobility [0-14 days prior to the first treatment and after completion of the anthracycline treatment.]
Assesed using the the Timed Up and Go (TUG) test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.