Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
- Conditions
- Familial Adenomatous Polyposis
- Interventions
- Drug: Calcumin (Curcumin)Other: Risk Factor QuestionnaireOther: Blood samplesOther: Biopsies (Sigmoidoscopy)Other: Biopsies (Upper endoscopy)
- Registration Number
- NCT00927485
- Lead Sponsor
- University of Puerto Rico
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 21-85 years with FAP (with an intact colon or who have had surgery)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Curcumin Calcumin (Curcumin) Curcumin Curcumin Biopsies (Sigmoidoscopy) Curcumin Placebo Blood samples Placebo (sugar pills) Curcumin Blood samples Curcumin Curcumin Risk Factor Questionnaire Curcumin Placebo Calcumin (Curcumin) Placebo (sugar pills) Placebo Risk Factor Questionnaire Placebo (sugar pills) Placebo Biopsies (Sigmoidoscopy) Placebo (sugar pills) Placebo Biopsies (Upper endoscopy) Placebo (sugar pills) Curcumin Biopsies (Upper endoscopy) Curcumin
- Primary Outcome Measures
Name Time Method Size of Polyps 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Puerto Rico Comprehensive Cancer Center
🇵🇷San Juan, Puerto Rico