Metformin Chemoprevention of Oral Premalignant Lesions
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Transformation-free-survival, in lesion types erythroplakia and verrucous hyperplasia
研究概览
简要总结
This phase I trial tests whether metformin works in reducing the annual transformation (development of invasive cancer) of oral precancerous lesions into cancerous lesions. Metformin is a drug approved for the treatment of diabetes, but studies have shown that it may have some anticancer properties. Giving metformin may help prevent or slow the development of oral cancer from precancerous lesions.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the transformation-free-survival in lesion types erythroplakia (EP) and verrucous hyperplasia (VH). 'Transformation' is defined as the development of invasive cancer.
SECONDARY OBJECTIVE:
I. To evaluate the current spontaneous regression rates, i.e., percentages of patients having lesion disappear within 1-year post treatment, in all four lesion types and compare them with historical documented regression rate in literature.
EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85
- •Clinical appearance of lesion
- •Homogenous leukoplakia
- •Non- homogenous leukoplakia
- •Erythroplakia
- •Proliferative verrucous leukoplakia
- •Histologic appearance
- •No dysplasia
- •Mild dysplasia
- •Moderate dysplasia
- •Severe dysplasia
- •Diabetics: if on metformin, will get them to 2000 mg per day, if not, will add metformin in consultation with endocrinologist
- •All subjects must be able to comprehend and sign a written informed consent document
- •Willing and able to be available for the duration of the study
- •In general good health with no contraindication to biopsy or metformin therapy
- •Laboratory results
排除标准
- •Carcinoma in-situ, verrucous carcinoma, invasive squamous cell carcinoma (SCCa)
- •Exclude systemic causes of the lesion: pemphigus, pemphigoid, systemic lupus erythematosus (SLE), lichenoid drug reaction, human immunodeficiency virus (HIV), syphilis
- •Exclude local inciting factors: rule out (r/o) but allowing 2 weeks to pass and see if there is resolution, if not and doesn't resolve with local measures, medical treatment, enroll
- •Frictional: sharp tooth
- •Immunosuppression by natural illness or medically induced
- •Hypersensitivity or allergic reaction to metformin or some other contraindication
研究组 & 干预措施
Prevention (metformin)
Patients receive metformin PO QD on days 1-3 and then PO BID for up to 12 months in the absence of unacceptable toxicity.
干预措施: Metformin (Drug)
Prevention (metformin)
Patients receive metformin PO QD on days 1-3 and then PO BID for up to 12 months in the absence of unacceptable toxicity.
干预措施: Biopsy (Procedure)
结局指标
主要结局
Transformation-free-survival, in lesion types erythroplakia and verrucous hyperplasia
时间窗: Up to 3 years
Will be summarized using Kaplan-Meier curves as well as 95% confidence ands. Kaplan-Meier estimates of the 3-year transformation-free-survival rates will be reported with 95% confidence interval. One-sample two-sided log-rank test will be applied to all four lesions as well.
次要结局
- Change in lesion status(Baseline to 1 year after treatment)