Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- The use of l-carnitine may be of use in extending the continuous use of anthracycline-containing chemotherapy
研究概览
简要总结
the study aim to protect patients received anthracyclines containing chemotherapy from cardiotoxcity induced by anthracyclines derivatives. by using L-carnitine and Silymarin for protection the heart from anthracyclines toxicities, and in addition its a comparitive study between L-carnitine and Silymarin.
详细描述
Aim: Anthracycline induced cardiotoxicity is the most common constrains of its use in treatment of various types of cancer. This study aimed to investigate benefits from adding L-carnitine and Silymarin compared to anthracycline chemotherapy alone in patients with cancer.
Methods: 83 patients were recruited from Clinical Oncology Department, Tanta University, Egypt, then prospectively randomized to receive their anthracycline containing therapeutic regimen, control group (n=33) or anthracycline plus L-carnitine, L-carnitine group (n=25), or anthracycline plus Silymarin, Silymarin group (n= 25). Blood samples were collected at begging and after 6 months to measure LDH, CK-MB, cTn I, Anticardiolipin IgG, Fe, ferritin and TIBC and % of saturation. % EF was documented. Data were statistically analyzed by ANOVA and paired t test. P <0.05 was statistically significant.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),
- •aged 20-60 and
- •female patients were included.
排除标准
- •patients with a history of heart failure, arrhythmia, history of cardiac catheterizations or, history of angina, uncontrolled hypertension and uncontrolled diabetes,
- •patients with impaired liver function tests,
- •previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens,
- •previous history of chest wall irradiation.
- •Brain metastasis,
- •pregnant patients and
- •patients who refused informed consent,
研究组 & 干预措施
control group
33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents
干预措施: L-Carnitine 500Mg Oral Tablet (Drug)
L-carnitine group
25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine
干预措施: L-Carnitine 500Mg Oral Tablet (Drug)
Silymarin group
25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg
干预措施: L-Carnitine 500Mg Oral Tablet (Drug)
结局指标
主要结局
The use of l-carnitine may be of use in extending the continuous use of anthracycline-containing chemotherapy
时间窗: from the baseline untill 3 months
addition of l-carnitine to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy
次要结局
- The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy(from the baseline untill 3 months)
研究者
hosny ahmed elewa
head of pharmacy practice department
Horus University