Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
rosuvastatin-group
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).
干预措施: Rosuvastatin 20mg (Drug)
结局指标
主要结局
change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
时间窗: 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
次要结局
- change of serum level of High sensitivity troponin I (hs-TnI).(6 months)
- change of serum level of Myeloperoxidase (MPO).(6 months)
- change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT).(6 months)
- change of serum level of Liver function test (ALT).(6 months)
研究者
Khlood Mohamed Kettana
demonstrator at clinical pharmacy department,faculty of pharmacy
Tanta University