Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Puerto Rico
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Size of Polyps
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •21-85 years with FAP (with an intact colon or who have had surgery)
Exclusion Criteria
- •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
Arms & Interventions
Curcumin
Curcumin
Intervention: Biopsies (Upper endoscopy) (Other)
Curcumin
Curcumin
Intervention: Calcumin (Curcumin) (Drug)
Curcumin
Curcumin
Intervention: Risk Factor Questionnaire (Other)
Curcumin
Curcumin
Intervention: Blood samples (Other)
Curcumin
Curcumin
Intervention: Biopsies (Sigmoidoscopy) (Other)
Placebo
Placebo (sugar pills)
Intervention: Calcumin (Curcumin) (Drug)
Placebo
Placebo (sugar pills)
Intervention: Risk Factor Questionnaire (Other)
Placebo
Placebo (sugar pills)
Intervention: Blood samples (Other)
Placebo
Placebo (sugar pills)
Intervention: Biopsies (Sigmoidoscopy) (Other)
Placebo
Placebo (sugar pills)
Intervention: Biopsies (Upper endoscopy) (Other)
Outcomes
Primary Outcomes
Size of Polyps
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Marcia R. Cruz-Correa, MD, PhD
Director of Gastrointestinal Oncology
University of Puerto Rico