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Ursodeoxycholic Acid

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Patients receive oral celecoxib twice daily and oral placebo twice daily

Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily

Celecoxib: 400mg twice daily, orally, 6 months

Ursodeoxycholic acid: orally, 6 months, dosage based on body weight:

below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses

Ursodeoxycholic acid

Placebo: orally, 6 months, dosage based on body weight:

below 50 kg: 1000mg, divided in two daily doses; 50-70 kg: 1500mg, divided in two daily doses; over 70 kg: 2000mg, divided in two daily doses

Placebo

Fokko M Nagengast, MD, Ph D

Bjorn WH van Heumen, MD

Wilbert HM Peters, Ph D

Ellen Kampman, Ph D

Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.

Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis

Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)

Dutch Cancer Society

Radboud University Medical Center

Antineoplastic Agents

Herbal and Botanical

Curcumin

Cola

Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Calcumin (Curcumin)

Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Risk Factor Questionnaire

Three tubes of blood at visits 0, 4 and 12 months.

Blood samples

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 (Sigmoidoscopy)

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.

Biopsies (Upper endoscopy)

Marcia R. Cruz-Correa, MD. PhD

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.

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.

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

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.

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.

National Institutes of Health (NIH)

University of Puerto Rico

Director of Gastrointestinal Oncology

Curcumin

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

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.

Placebo (sugar pills)

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis	NCT00808743	Familial Adenom... Duodenal Neopla... Duodenal Polyps	Celecoxib Ursodeoxycholic... Placebo	18 Years - 70 Years	Radboud University Medical Center
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)	NCT00927485	Familial Adenom...	Calcumin (Curcu... Risk Factor Que... Blood samples Biopsies (Sigmo... Biopsies (Upper...	21 Years - 85 Years	University of Puerto Rico
Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis	NCT00808743	Familial Adenom... Duodenal Neopla... Duodenal Polyps	Celecoxib Ursodeoxycholic... Placebo	18 Years - 70 Years	Radboud University Medical Center

Spots Global Cancer Trial Database for duodenal polyps