Breast Cancer, Chemotherapy-induced Cardiotoxicity
Conditions
Brief summary
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.
Interventions
DRUGRosuvastatin 20mg
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).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 25-75 years old. * Gender: female * Newly diagnosed HER2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 * Preserved LV systolic function in which the left ventricular ejection fraction (LVEF)≥50%. * Patients with normal renal and hematological functions. * Alanine amino transferase (ALT ≤ 3 times ULN).
Exclusion criteria
* Pregnant or lactating females. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 2 * Patients with impaired LV systolic function in which the left ventricular ejection fraction (LVEF)\<50%. * Patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy. * Alanine amino transferase (ALT \> 3 times ULN). * Patients already taking statins or other lipid lowering therapy. * Patients with a known hypersensitivity to any of the used drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of serum level of High sensitivity troponin I (hs-TnI). | 6 months | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate High sensitivity troponin I (hs-TnI). |
| change of serum level of Myeloperoxidase (MPO). | 6 months | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Myeloperoxidase (MPO). |
| change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT). | 6 months | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Interleukin-6 (IL-6). |
| change of serum level of Liver function test (ALT). | 6 months | Blood samples will be collected at baseline, after 3 months and after 6 months to evaluate Liver function test (ALT). |
Countries
Egypt
Outcome results
None listed