The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon

This study has been terminated.
(principal Investigator left institution)
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176618
First received: September 13, 2005
Last updated: December 10, 2009
Last verified: December 2009

September 13, 2005
December 10, 2009
April 2004
June 2007   (final data collection date for primary outcome measure)
To evaluate the effects of curcumin or the NSAID sulindac on the number of ACF in the left colon and rectum of normal volunteers found to have them on an initial magnifying chromoendoscopic screening exam [ Time Frame: 48 months ] [ Designated as safety issue: No ]
To evaluate the effects of curcumin or the NSAID sulindac on the number of ACF in the left colon and rectum of normal volunteers found to have them on an initial magnifying chromoendoscopic screening exam.
Complete list of historical versions of study NCT00176618 on ClinicalTrials.gov Archive Site
To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment [ Time Frame: 48 months ] [ Designated as safety issue: No ]
To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment.
Not Provided
Not Provided
 
The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon

The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon.

Laboratory studies have indicated that this agent, which is derived from plants and found in foods we eat, has anti-inflammatory properties and prevents colon cancer in animal studies. ACFs are small abnormalities in the lining of the colon that with time may grow into colorectal adenomas (also called polyps, growths or small masses of tissue on the lining of the colon or rectum which have the potential to become cancerous) which can then grow into adenocarcinomas (cancer) in the colon or rectum.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Aberrant Crypt Foci
  • Drug: sulindac
    Sulindac 150 mg po BID
  • Drug: curcumin
    Curcumin 250 mg po BID
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be eligible for colorectal cancer (CRC) screening/surveillance by current criteria.
  • Subjects must have at least 5 ACF on eligibility chromosigmoidoscopy examination.

Exclusion Criteria:

Subjects must not have:

  • Alcohol consumption of greater than 2 glasses of wine or beer per day or illicit recreational drug use
  • Platelet or coagulation abnormalities, or personal history of a bleeding disorder, including individuals taking warfarin.
  • High risk for developing endocarditis (history of endocarditis or rheumatic fever, cardiac valve prostheses, or mitral valve prolapse that requires antibiotic prophylaxis).
  • Uncontrolled hypertension, diabetes, or chronic congestive heart failure.
  • Renal insufficiency defined as a serum creatinine > 2.5 mg/dl
  • History of colorectal surgery with removal of the distal 60 cm of colon or rectum.
  • History of other gastrointestinal mucosal epithelial diseases (such as Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue or other disorders of nutrient absorption).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176618
4611, CINJ#120305
Not Provided
C. S. Yang, PhD, The Cancer Institute of New Jersey
University of Medicine and Dentistry of New Jersey
Not Provided
Principal Investigator: Yang CS, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
December 2009

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