IGF::OT::IGF M4OC-PREVENT: METFORMIN FOR ORAL CANCER PREVENTION

拟议的临床试验将探讨二甲双胍在预防口腔癌方面是否有效。这是一项IIa期临床试验，二甲双胍ER每天2000毫克，连续12-14周给患有口腔癌前病变的个体，无论是口腔白斑还是红斑（口腔癌的前体）。目的是确定二甲双胍是否能减少口腔白斑的大小（临床反应）。此外，对癌症风险和二甲双胍效应的生物标志物的影响也将被确定。临床试验将在加州大学圣地亚哥分校摩尔癌症中心、明尼苏达大学和不列颠哥伦比亚省癌症机构进行，由亚利桑那大学提供监测和监督。

The proposed clinical trial shall address whether metformin has utility in the prevention of oral cancer. It is a phase IIa clinical trial of metformin ER 2,000 mg per day given for 12-14 weeks to individuals with oral premalignant lesions, either oral leukoplakia or erythroplakia (which are precursors to oral cancer). The goal is to determine if metformin decreases the size of oral leukoplakia (clinical response). Additionally, effects on biomarkers of cancer risk and metformin effect will also be ascertained. The clinical trial shall be performed at the University of California San Diego Moores Cancer Center, the University of Minnesota, and the British Columbia Cancer Agency, with monitoring and oversight provided by the University of Arizona.