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the study aims to evaluate the cardioprotective effect of atorvastatin in breast cancer female patients treated with doxorubicin based chemotherapy
female patients with newly diagnosed breast cancer, who are candidates for AC protocol will be recruited from Damanhour oncology center.
All enrolled patients will be randomly assigned into 2 arms:
All patients will be submitted to:
All patients will be followed up during 3 months' period. At the end of 3 months, Serum samples will be collected from patients for measuring the biomarkers. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 8. Measuring outcome: The primary outcome is the change of serum levels of the measured cardiac biomarkers after 4 cycles of AC regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control arm | No Intervention | ||
| atorvastatin arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | atorvastatin 40 mg orally once daily for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| cardiac biomarkers (NT-Pro BNP, ST2 and MPO) | change from baseline in Serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), suppression of tumorigenicity-2 (ST2), myeloperoxidase (MPO), and cholesterol using enzyme-linked immunosorbent assay (ELISA) kits and standard biochemical methods according to manufacturer instructions | baseline and 3 months ( after completion of 4 cycles of AC chemotherapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gamal Omran, phD | Faculty of pharmacy | Study Chair |
| Noha El-Bassiouny, phD | Faculty of pharmacy | Study Chair |
| Amira B Kassem, PhD | Faculty of pharmacy | Study Director |
| Mohamed omar | Damanhour Oncology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhour university | Beheira | Damanhour | 22511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19147586 | Background | Riad A, Bien S, Westermann D, Becher PM, Loya K, Landmesser U, Kroemer HK, Schultheiss HP, Tschope C. Pretreatment with statin attenuates the cardiotoxicity of Doxorubicin in mice. Cancer Res. 2009 Jan 15;69(2):695-9. doi: 10.1158/0008-5472.CAN-08-3076. | |
| 33401953 | Background | Abdel-Qadir H, Bobrowski D, Zhou L, Austin PC, Calvillo-Arguelles O, Amir E, Lee DS, Thavendiranathan P. Statin Exposure and Risk of Heart Failure After Anthracycline- or Trastuzumab-Based Chemotherapy for Early Breast Cancer: A Propensity Score-Matched Cohort Study. J Am Heart Assoc. 2021 Jan 19;10(2):e018393. doi: 10.1161/JAHA.119.018393. Epub 2021 Jan 6. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 23141499 | Background | Seicean S, Seicean A, Plana JC, Budd GT, Marwick TH. Effect of statin therapy on the risk for incident heart failure in patients with breast cancer receiving anthracycline chemotherapy: an observational clinical cohort study. J Am Coll Cardiol. 2012 Dec 11;60(23):2384-90. doi: 10.1016/j.jacc.2012.07.067. Epub 2012 Nov 7. |
| 28102848 | Background | Henninger C, Fritz G. Statins in anthracycline-induced cardiotoxicity: Rac and Rho, and the heartbreakers. Cell Death Dis. 2017 Jan 19;8(1):e2564. doi: 10.1038/cddis.2016.418. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |