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

21 Years
85 Years
Open (Enrolling)
Familial Adenomatous Polyposis

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Trial Information

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

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.

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 >

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Marcia R. Cruz-Correa, MD. PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Puerto Rico


United States: Food and Drug Administration

Study ID:

Protocol A2210108-UPR



Start Date:

November 2007

Completion Date:

November 2016

Related Keywords:

  • Familial Adenomatous Polyposis
  • Familial Adenomatous Polyposis (FAP)
  • Curcumin
  • Colorectal polyps
  • Duodenal polyps
  • Adenoma
  • Adenomatous Polyposis Coli
  • Colorectal Neoplasms
  • Nasopharyngeal Neoplasms