Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Size of Polyps
研究概览
简要总结
Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.
Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.
详细描述
Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-85 years with FAP (with an intact colon or who have had surgery)
排除标准
- •Mentally incompetent
- •Female patients of childbearing age not on effective birth control
- •Patients with WBC < 3,500/ml, platelet count < 100,000/ml, BUN > 25mg%, creatinine > 1.5mg%
- •Patients unable to stop NSAIDS or aspirin use for the duration of the study
- •Malignancy other than nonmelanoma skin cancer
- •Active bacterial infection
- •Patients with GERD (Gastro esophageal reflux disease)
- •Patients with a history of peptic (stomach or duodenal) ulcer disease
- •Patients on Warfarin or anti-platelet drugs
研究组 & 干预措施
Curcumin
Curcumin
干预措施: Biopsies (Upper endoscopy) (Other)
Curcumin
Curcumin
干预措施: Calcumin (Curcumin) (Drug)
Curcumin
Curcumin
干预措施: Risk Factor Questionnaire (Other)
Curcumin
Curcumin
干预措施: Blood samples (Other)
Curcumin
Curcumin
干预措施: Biopsies (Sigmoidoscopy) (Other)
Placebo
Placebo (sugar pills)
干预措施: Calcumin (Curcumin) (Drug)
Placebo
Placebo (sugar pills)
干预措施: Risk Factor Questionnaire (Other)
Placebo
Placebo (sugar pills)
干预措施: Blood samples (Other)
Placebo
Placebo (sugar pills)
干预措施: Biopsies (Sigmoidoscopy) (Other)
Placebo
Placebo (sugar pills)
干预措施: Biopsies (Upper endoscopy) (Other)
结局指标
主要结局
Size of Polyps
时间窗: 5 years
To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp size in patients with FAP.
Number of Polyps
时间窗: 5 years
To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number in patients with FAP.
次要结局
未报告次要终点
研究者
Marcia R. Cruz-Correa, MD, PhD
Director of Gastrointestinal Oncology
University of Puerto Rico
