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临床试验/NCT00927485
NCT00927485已完成不适用

Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

University of Puerto Rico1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Curcumin

干预措施: Biopsies (Upper endoscopy) (Other)

Curcumin

Experimental

Curcumin

干预措施: Calcumin (Curcumin) (Drug)

Curcumin

Experimental

Curcumin

干预措施: Risk Factor Questionnaire (Other)

Curcumin

Experimental

Curcumin

干预措施: Blood samples (Other)

Curcumin

Experimental

Curcumin

干预措施: Biopsies (Sigmoidoscopy) (Other)

Placebo

Placebo Comparator

Placebo (sugar pills)

干预措施: Calcumin (Curcumin) (Drug)

Placebo

Placebo Comparator

Placebo (sugar pills)

干预措施: Risk Factor Questionnaire (Other)

Placebo

Placebo Comparator

Placebo (sugar pills)

干预措施: Blood samples (Other)

Placebo

Placebo Comparator

Placebo (sugar pills)

干预措施: Biopsies (Sigmoidoscopy) (Other)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcia R. Cruz-Correa, MD, PhD

Director of Gastrointestinal Oncology

University of Puerto Rico

研究点 (1)

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