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

Familial Adenomatous Polyposis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927485
• Other study ID #: Protocol A2210108-UPR
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Est. completion date: December 2016

Study information

• Verified date: November 2020
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyposis Coli
• Colorectal Neoplasms
• Familial Adenomatous Polyposis
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Other:
• Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.
• Blood samples
Three tubes of blood at visits 0, 4 and 12 months.
• Biopsies (Sigmoidoscopy)
Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.
• Biopsies (Upper endoscopy)
Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico Comprehensive Cancer Center	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
University of Puerto Rico	National Institutes of Health (NIH)

Country where clinical trial is conducted

Puerto Rico, 

References & Publications (1)

Cruz-Correa M, Hylind LM, Marrero JH, Zahurak ML, Murray-Stewart T, Casero RA Jr, Montgomery EA, Iacobuzio-Donahue C, Brosens LA, Offerhaus GJ, Umar A, Rodriguez LM, Giardiello FM. Efficacy and Safety of Curcumin in Treatment of Intestinal Adenomas in Pat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Polyps	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.	5 years
Primary	Size of Polyps	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.	5 years