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Clinical Trials/NCT00927485
NCT00927485
Completed
Not Applicable

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

University of Puerto Rico1 site in 1 country44 target enrollmentStarted: November 2007Last updated:

Overview

Phase
Not Applicable
Status
Completed
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

Experimental

Curcumin

Intervention: Biopsies (Upper endoscopy) (Other)

Curcumin

Experimental

Curcumin

Intervention: Calcumin (Curcumin) (Drug)

Curcumin

Experimental

Curcumin

Intervention: Risk Factor Questionnaire (Other)

Curcumin

Experimental

Curcumin

Intervention: Blood samples (Other)

Curcumin

Experimental

Curcumin

Intervention: Biopsies (Sigmoidoscopy) (Other)

Placebo

Placebo Comparator

Placebo (sugar pills)

Intervention: Calcumin (Curcumin) (Drug)

Placebo

Placebo Comparator

Placebo (sugar pills)

Intervention: Risk Factor Questionnaire (Other)

Placebo

Placebo Comparator

Placebo (sugar pills)

Intervention: Blood samples (Other)

Placebo

Placebo Comparator

Placebo (sugar pills)

Intervention: Biopsies (Sigmoidoscopy) (Other)

Placebo

Placebo Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marcia R. Cruz-Correa, MD, PhD

Director of Gastrointestinal Oncology

University of Puerto Rico

Study Sites (1)

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