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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Troponin I | 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 | Resting blood pressure assesed by sphyngomanometer |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of Life | 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). |
| Fatigue |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María Alonso | Contact | + 34 678942096 | maria.alonsod@alumnos.upm.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Ramón y Cajal" Hospital | Recruiting | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 24-48 hours prior to each cycle of anthracyclines and immediately prior to receiving the treatment |
| Left Ventricular Ejection Fraction (LVEF) | 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). |
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 | 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 | 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 | 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 | Assesed using the hand grip dynamometer test | 0-14 days prior to the first treatment and immediately after completion of the anthracycline treatment. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |