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

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ClinicalTrials.gov Identifier: NCT00927485
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico

Brief 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.


Condition or disease Intervention/treatment Phase
Familial Adenomatous Polyposis Drug: Calcumin (Curcumin) Other: Risk Factor Questionnaire Other: Blood samples Other: Biopsies (Sigmoidoscopy) Other: Biopsies (Upper endoscopy) Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Study Start Date : November 2007
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Curcumin
Curcumin
Drug: Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Other Name: Curcumin

Other: Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Other: Blood samples
Three tubes of blood at visits 0, 4 and 12 months.

Other: 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.

Other: 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 Comparator: Placebo
Placebo (sugar pills)
Drug: Calcumin (Curcumin)
Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).
Other Name: Curcumin

Other: Risk Factor Questionnaire
Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Other: Blood samples
Three tubes of blood at visits 0, 4 and 12 months.

Other: 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.

Other: 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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 5 years ]


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927485


Locations
Puerto Rico
University of Puerto Rico Comprehensive Cancer Center
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
University of Puerto Rico
Investigators
Principal Investigator: Marcia R. Cruz-Correa, MD. PhD University of Puerto Rico Comprehensive Cancer Center

Publications of Results:
Responsible Party: Marcia R. Cruz-Correa, MD, PhD, Director of Gastrointestinal Oncology, University of Puerto Rico
ClinicalTrials.gov Identifier: NCT00927485     History of Changes
Other Study ID Numbers: Protocol A2210108-UPR
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Keywords provided by Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico:
Familial Adenomatous Polyposis (FAP)
Curcumin
Colorectal polyps
Duodenal polyps

Additional relevant MeSH terms:
Curcumin
Adenoma
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Adenomatous Polyps
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic