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Curcumin in Treating Patients With Familial Adenomatous Polyposis

This study is currently recruiting participants.
Verified March 2013 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: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Familial Adenomatous Polyposis
 Drug: curcumin
Other: placebo
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

Resource links provided by NLM:

Drug Information available for: Curcumin
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (curcumin)
Patients receive curcumin PO BID for 12 months.
 Drug: curcumin
Given PO
Other Names:
  • C.I. 75300
  • C.I. Natural Yellow 3
  • CU
  • Diferuloylmethane
Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 12 months.
 Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641147

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287-8936
Contact: Francis M. Giardiello     410-955-2635     fgiardi@jhmi.edu    
Principal Investigator: Francis M. Giardiello            
Puerto Rico
University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00936
Contact: Marcia R. Cruz-Correa     787-765-2363     marcia.cruz1@upr.edu    
Principal Investigator: Marcia R. Cruz-Correa            
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Francis Giardiello Johns Hopkins University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00641147     History of Changes
Other Study ID Numbers: NCI-2013-00536, 00011821, R01CA134620
Study First Received: March 17, 2008
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013