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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

Tracking Information
First Submitted Date  ICMJE June 24, 2009
First Posted Date  ICMJE June 25, 2009
Last Update Posted Date October 17, 2018
Study Start Date  ICMJE November 2007
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
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: 3-5 years ]
Change History Complete list of historical versions of study NCT00927485 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Official Title  ICMJE Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Familial Adenomatous Polyposis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Curcumin
    Curcumin
    Interventions:
    • Drug: Calcumin (Curcumin)
    • Other: Risk Factor Questionnaire
    • Other: Blood samples
    • Other: Biopsies (Sigmoidoscopy)
    • Other: Biopsies (Upper endoscopy)
  • Placebo Comparator: Placebo
    Placebo (sugar pills)
    Interventions:
    • Drug: Calcumin (Curcumin)
    • Other: Risk Factor Questionnaire
    • Other: Blood samples
    • Other: Biopsies (Sigmoidoscopy)
    • Other: Biopsies (Upper endoscopy)
Publications * 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 Patients With Familial Adenomatous Polyposis. Gastroenterology. 2018 Sep;155(3):668-673. doi: 10.1053/j.gastro.2018.05.031. Epub 2018 May 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
44
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2009)
50
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00927485
Other Study ID Numbers  ICMJE Protocol A2210108-UPR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marcia R. Cruz-Correa, MD, PhD, University of Puerto Rico
Study Sponsor  ICMJE University of Puerto Rico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marcia R. Cruz-Correa, MD. PhD University of Puerto Rico Comprehensive Cancer Center
PRS Account University of Puerto Rico
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP