Clinical trial NCT05467111: Cardioprotective Effect of Acute Exercise in Breast Cancer Patients
Official title: Cardioprotective Effect of Acute Exercise in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early-stage Breast Cancer
Keywords: Breast Cancer
Exercise
Doxorubicin
anthracyclines
Cardiotoxicity
Lead sponsor: Technical University of Madrid
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: NT-proBNP
timeFrame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
Secondary outcomes:
measure: Cardiac Troponin I
timeFrame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
measure: Blood Pressure
timeFrame: 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 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:
measure: Changes in Quality of Life
timeFrame: Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
measure: Fatigue
timeFrame: Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
measure: Physical Activity
timeFrame: Prior to each exercise session and in the follow-up period (6 months after completion of the anthracycline treatment).
measure: Assessment of functional mobility
timeFrame: 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
measure: Assessment of lower extremity strength and power
timeFrame: 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
measure: Assessment of isometric handgrip
timeFrame: 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment.
Locations:
city: Madrid
country: Spain
facility: "Ramón y Cajal" Hospital
Study officials:
References: