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This study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control-group | No Intervention | This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy. | |
| rosuvastatin-group | Active Comparator | This group will include 25 patients who will receive doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy in addition to 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 20mg | Drug | 20 mg of oral rosuvastatin 24 hours prior to the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months). |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography | Patients will undergo transthoracic echocardiography 24 hours prior to the initiation of chemotherapy, after 3 months and after 6 months to detect change in LVEF | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change of serum level of High sensitivity troponin I (hs-TnI). | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate High sensitivity troponin I (hs-TnI). | 6 months |
| change of serum level of Myeloperoxidase (MPO). |
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Inclusion Criteria:
Exclusion Criteria:
only female patients are included in the study
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| Name | Affiliation | Role |
|---|---|---|
| khlood m. kettana | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Department of Clinical Oncology, Tanta University Hospital | Tanta | Egypt |
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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 |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Myeloperoxidase (MPO). |
| 6 months |
| change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT). | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Interleukin-6 (IL-6). | 6 months |
| change of serum level of Liver function test (ALT). | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT). | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |