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

IGF::OT::IGF M4OC-预防：二甲双胍用于预防口腔癌

• 批准号: 9162592
• 负责人: SHERRY CHOW
• 金额: $ 72.22万
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9162592
• 关键词: Address; Arizona; Biological Markers; Blood; British Columbia; C-Peptide; California; Clinical; Clinical Trials; DNA; Epidermal Growth Factor Receptor; Erythroplasia; Genes; Glucose; Glycosylated hemoglobin A; Goals; Growth; Histologic; Individual; Inflammatory; Interleukin-6; Interleukin-8; Intervention; Lesion; Malignant Neoplasms; Metabolic; Metformin; Molecular; Molecular Target; Monitor; Oncogenes; Oral; Oral Leukoplakia; Organic Cation Transporter; PTEN gene; Phase; Premalignant; Saliva; Serum; Tissues; Universities; University of Minnesota Cancer Center; Vascular Endothelial Growth Factors; base; cancer risk; cytokine; malignant mouth neoplasm; oral cancer prevention; prevent; response

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.

拟定的临床试验应说明二甲双胍是否可用于预防口腔癌。这是一项IIa期临床试验，二甲双胍ER 2，000 mg/天，持续12-14周，用于口腔癌前病变，口腔白斑或红斑（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，还将确定对癌症风险生物标志物的影响和二甲双胍效应。 临床试验应在加州大学圣地亚哥摩尔癌症中心、明尼苏达大学和不列颠哥伦比亚省癌症机构进行，由亚利桑那大学进行监查和监督。