NCT01877564已完成2 期
A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- IHC-based Tissue Markers of Proliferation
研究概览
简要总结
The purpose of this research is to determine the effects of Metformin, a well tolerated drug widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological confirmed diagnosis of grade I or II adenocarcinoma of the endometrium
- •Must be obese as defined by a body mass index (BMI) greater than or equal to 30 kg/m2
- •Candidate for surgical removal of their uterus as part of their endometrial cancer treatment
- •Subjects must have signed informed consent
- •Age 42 - 65 years of age
- •Electrocorticogram (ECOG) Performance status of 0 - 2
- •History of adequate renal, liver, and bone marrow function:
- •Hb: (adequate for surgical intervention, with transfusion if necessary) White Blood Cell (WBC): (normal range)
- •Platelets: (180K/cmm)
- •Liver Function Test(LFTs): Normal bilirubin (<2.0mg/dL), AST/ALT (2xULN)
- •Renal function: creatinine less than 1.4
- •Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of randomization to Metformin. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.
排除标准
- •Poorly differentiated cancer or any of the high-risk subtypes of endometrial cancer including serous, clear cell, or carcinosarcoma
- •History of diabetes mellitus Type 1 or Type
- •Receiving metformin prior to enrollment
- •Known hypersensitivity to metformin.
- •Unable to swallow and retain oral medication.
- •Pregnant or lactating.
- •Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for > 5 years
- •If the physician feels that the candidate is not suitable for the study, he/she will be excluded.
- •Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR or DPP-4 inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
- •Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.
- •History of lactic or other metabolic acidosis.
- •Uncontrolled infectious disease.
- •History of positivity for human immunodeficiency virus (HIV).
- •History of congestive heart failure requiring pharmacologic treatment.
- •History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.
- •Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
- •Current use of medications for weight loss.
- •Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted.
研究组 & 干预措施
Group 1 - Metformin
Experimental
oral metformin at 500 mg twice a day for 14-21 days followed by surgery
干预措施: Metformin (Drug)
结局指标
主要结局
IHC-based Tissue Markers of Proliferation
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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