Effect of Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells : a Randomized Double Blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of Ki-67 expression in endometrial tumor
研究概览
简要总结
Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.
详细描述
Endometrial cancer is one of the most common gynecological cancers. Preclinical studies in endometrial cancer (EC) show that metformin reduces cellular proliferation by PI3K-AKT-mTOR inhibition. The investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. However, no good quality of evidence base supports the effectiveness of metformin for deceasing proliferative marker in endometrial cancer.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study
排除标准
- •Women without diabetes type 1 and 2
- •Women who have allergy Biguanide
- •Women who have hypoglycemic medication
- •Women who have GFR <45 ml/min/1.73 m2
- •Women who have evidence of stage 3 or 4 of endometrial cancer
研究组 & 干预措施
metformin
The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy
干预措施: Metformin Hydrochloride 850 MG (Drug)
placebo
The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change of Ki-67 expression in endometrial tumor
时间窗: 4 weeks
metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy.
次要结局
- Change of grade in endometrial tumor(4 weeks)