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

University of Puerto Rico (UPR)

Status: Completed

Conditions: Familial Adenomatous Polyposis

Treatments: Other: Blood samples; Drug: Calcumin (Curcumin); Other: Risk Factor Questionnaire; Other: Biopsies (Upper endoscopy); Other: Biopsies (Sigmoidoscopy)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00927485

Protocol A2210108-UPR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

44 participants in 2 patient groups, including a placebo group

Curcumin

Experimental group

Description:

Curcumin

Treatment:

Other: Biopsies (Upper endoscopy)

Other: Biopsies (Sigmoidoscopy)

Other: Blood samples

Other: Risk Factor Questionnaire

Drug: Calcumin (Curcumin)

Placebo

Placebo Comparator group

Description:

Placebo (sugar pills)

Treatment:

Other: Biopsies (Upper endoscopy)

Other: Biopsies (Sigmoidoscopy)

Other: Blood samples

Other: Risk Factor Questionnaire

Drug: Calcumin (Curcumin)