NCT00909506已完成2 期
Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients
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
- 105
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
The investigators hypothesize that adjuvant metformin use in breast cancer patients with overweight or pre-diabetes mellitus (DM) may improve their body condition including weight loss.
In this study, the investigators aim to test the efficacy and safety of adjuvant metformin for operable breast cancer patients with overweight or pre-DM.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Operable Breast cancer patients with BMI ≥ 23 or 100 ≤ FBS < 126
- •From 6 month to 2 years since breast cancer operation and at least 4 weeks since chemotherapy or radiotherapy
- •No drug use except Tamoxifen
- •Normal OTPT & Serum creatinine (<=ULN)
- •ECOG performance status 0-2 or Karnofsky PS 60-100%
- •Life expectancy > 12
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Platelets ≥ 100 x 10^9/L
- •Pregnancy(-) & without plan for pregnancy
- •Sign a written informed consent form
排除标准
- •Type I or II DM or concurrent use of DM control agents
- •Prior use of Metformin
- •Hypoglycemia (FBS< 70 with clinical symptom)
- •Concurrent investigational or commercial agents
- •Other diet or drug intervention for weight loss
- •Concurrent use of steroid
- •Abnormal liver and/or renal function
- •Symptomatic congestive heart failure / Cardiac arrhythmia / Angina pectoris
- •Ongoing or active infection
- •lactic acidosis
- •Pregnancy or ongoing breast feeding
- •Anorexia, bulimia, nausea due to other disease for longer than 1 month
- •Allergies or allergic reactions attributed to oral medications
- •Inability to swallow or digest oral medications
- •Physical or psychiatric illness that would limit compliance with study protocol
- •Participants in other clinical trial
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Metformin 500 mg/d
Active Comparator
Metformin 500 mg/d
干预措施: Metformin (Drug)
Metformin 1000 mg/d
Active Comparator
Metformin 1000 mg/d
干预措施: Metformin (Drug)
结局指标
主要结局
Weight loss
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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