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Completed

NCT Number: NCT00927485

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcumin (Curcumin)

Drug

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

Other names: Curcumin

Risk Factor Questionnaire

Other

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

Blood Samples

Other

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

Biopsies (Sigmoidoscopy)

Other

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

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2009
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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