Curcumin in Treating Patients With Familial Adenomatous Polyposis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00641147
First received: March 17, 2008
Last updated: July 28, 2014
Last verified: March 2014

March 17, 2008
July 28, 2014
October 2010
June 2015   (final data collection date for primary outcome measure)
Total number of polyps [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]
The average number of polyps in the treatment groups will be compared by the t-test (or a distribution free analog if distribution assumptions are not met). Multivariate regression models will be used to adjust for strongly predictive factors that are not balanced in the treatment groups.
polyp number and size [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00641147 on ClinicalTrials.gov Archive Site
  • Mean polyp size in mm (mean size of the 5 largest polyps) [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]
    Continuous variables relating to colorectal proliferation and polyp size will be compared in the two treatment groups by parametric statistics.
  • Number of patients failing study [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]
  • Ornithine decarboxylase activity expressed as nmol of activity/mg of musosal tissue/hr [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Ornithine decarboxylase activity expressed as nmol of activity/mg of musosal tissue/hr [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Polyamines expressed pg/mg protein [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Polyamines expressed pg/mg protein [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mucosal DNA methylation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Mucosal DNA methylation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Ki-67 anti-proliferative cell nuclear antibody index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Ki-67 anti-proliferative cell nuclear antibody index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Apoptosis index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Apoptosis index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Vascular density [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Vascular density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mucosal prostaglandin levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Mucosal prostaglandin levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mucosal leukotriene levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Mucosal leukotriene levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mucosa and adenoma histology by light microscopy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Mucosa and adenoma histology by light microscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Activation of NFKB pathway [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Activation of NFKB pathway [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Phosphorylation of Akt [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Phosphorylation of Akt [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Side effects of curcumin treatment [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Medication compliance [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
side effects and medication compliance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Curcumin in Treating Patients With Familial Adenomatous Polyposis
Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

This clinical trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.

PRIMARY OBJECTIVES:

I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir) surgery.

II. To measure markers of cell proliferation including colorectal mucosal levels of ornithine decarboxylase (ODC), polyamines, mucosal DNA methylation, proliferative index (Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal prostaglandin, leukotriene levels, and activation of the nuclear factor kappa B (NFKB), and Akt survival pathways.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.

ARM II: Patients receive placebo PO BID for 12 months.

After completion of study treatment, patients are followed up at 4 months.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Familial Adenomatous Polyposis
  • Other: placebo
    Given PO
    Other Name: PLCB
  • Other: laboratory biomarker analysis
    Correlative studies
  • Drug: curcumin
    Given PO
    Other Names:
    • C.I. 75300
    • C.I. Natural Yellow 3
    • CU
    • Diferuloylmethane
  • Experimental: Arm I (curcumin)
    Patients receive curcumin PO BID for 12 months.
    Interventions:
    • Other: laboratory biomarker analysis
    • Drug: curcumin
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO BID for 12 months.
    Interventions:
    • Other: placebo
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total coloctomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir
  • Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. s/p ileostomy

Exclusion Criteria:

  • Female patients of childbearing age not on effective birth control
  • Pregnant women
  • WBC < 3500/ml
  • Platelet count < 100,000/ml
  • BUN > 25mg%
  • Creatinine > 1.5mg%
  • Patients unable to stop NSAIDS, aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial
  • Malignancy other than nonmelanoma skin cancer
  • Active bacterial infection
  • Patients with symptoms of active GERD (symptomatic despite medication or current erosive esophagitis on endoscopy)
  • Patients with a history of peptic ulcer disease
  • Patients on Warfarin or Plavix
Both
18 Years to 85 Years
No
United States,   Puerto Rico
 
NCT00641147
NCI-2013-00536, NCI-2013-00536, CDR0000592794, NA_00011821, 00011821, R01-CA-134620, R01-CA-134620, R01CA134620, P30CA006973
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Francis Giardiello Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
March 2014

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