NCT02083692已完成早期 1 期
Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling.
Sidney Kimmel Cancer Center at Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年9月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in TOMM20 and MCT4 expression from tumor cells from date of biopsy and date of surgery
研究概览
简要总结
The purpose of this study is to assess the effect of metformin in tumor metabolism in patients with head and neck cancer by evaluating metformin's ability to decrease TOMM20 expression in squamous carcinoma cells and decrease MCT4 expression in fibroblasts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of head and neck cancer biopsy proven, and who have a scheduled appointment for definitive resection of the tumor at TJUH
- •Age ≥ 18 years of age and ≤80 years old.
- •Newly diagnosed with HNSCC cancer.
- •No prior therapy for HNSCC cancer is permitted for enrollment in the trial.
- •All subjects must be able to comprehend and sign a written informed consent document.
排除标准
- •Pregnant or may become pregnant during metformin administration.
- •On metformin for any reason during the preceding 4 weeks.
- •Diabetic patients are eligible if they are not taking metformin, insulin or sulfonylureas.
- •Received iodinated contrast dye less than 48 hours prior to screening meet a temporary exclusion criteria to receive metformin. These patients cannot start investigational metformin until 48 hours have elapsed from contrast administration. Subjects who are scheduled for iodinated contrast dye administration within 48 hours of definitive surgery are excluded.
- •Plasma alanine aminotransferase greater than 40 IU/dL.
- •Plasma aspartate aminotransferase greater than 45 IU/dL.
- •Plasma creatinine level greater than 1.3 mg/dL.
- •Plasma alkaline phosphatase greater than 190 IU/dL.
- •Plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis.
- •History of congestive heart failure.
- •Myocardial ischemia or peripheral muscle ischemia.
- •Sepsis or severe infection.
- •History of lung disease currently requiring any pharmacologic or supplemental oxygen treatment.
- •Scheduled for definitive HNSCC cancer surgical resection less than two weeks from enrollment or greater than five weeks from enrollment.
- •History of hepatic dysfunction or hepatic disease.
- •Excessive alcohol intake which is defined in accordance with CDC definitions as more than 1 drink per day for women and more than 2 drinks per day for men.
- •All medications are permitted except those that are contraindicated with metformin under current FDA recommendations.
研究组 & 干预措施
Metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
Change in TOMM20 and MCT4 expression from tumor cells from date of biopsy and date of surgery
时间窗: date of biopsy and date of surgery (9-28 days)
次要结局
未报告次要终点
研究者
研究点 (1)
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