Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- IGF-1 levels
研究概览
简要总结
The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.
详细描述
One hundred and seven women with metastatic breast cancer (MBC) are randomly assigned to either a metformin (500 mg twice daily) or placebo (placebo) group during chemotherapy. All patients followed the standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI). Blood IGF-1 levels were measured at the start of treatment (baseline) and again six months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients with MBC
- •patients older than 18
- •nondiabetic patients
- •patients who received only chemotherapy
排除标准
- •patients with non-metastatic breast cancer
- •patients receiving hormonal therapy or radiotherapy
- •patients with diabetes
- •history of cardiac diseases
- •hypersensitivity, or allergy to metformin.
研究组 & 干预措施
Metformin and Chemotherapy
Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
Metformin and Chemotherapy
Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)
干预措施: Chemotherapy (Drug)
Chemotherapy alone
Chemotherapy is administered alone to Group B (n=50).
干预措施: Chemotherapy (Drug)
结局指标
主要结局
IGF-1 levels
时间窗: 6 months.
IGF-1 levels were measured before and after treatment.
次要结局
- Progression-free survival (PFS)(1 Year)
研究者
Marian S. Boshra
Dr.
Beni-Suef University