Early-stage Breast Cancer
Conditions
Keywords
Breast Cancer, Exercise, Doxorubicin, anthracyclines, Cardiotoxicity
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.
Interventions
OTHERAcute 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.
Sponsors
Technical University of Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of lower extremity strength and power | 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment. | Assesed using the Sit to Stand test |
| Changes in 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 |
| Assessment of isometric handgrip | 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment. | Assesed using the hand grip dynamometer test |
| 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 immediately after completion of the anthracycline treatment. | Assesed using the Timed Up and Go (TUG) test |
Countries
Spain
Contacts
Primary ContactMaría Alonso
Outcome results
None listed