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
  Purpose

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


Condition Intervention
Aberrant Crypt Foci
Drug: sulindac
Drug: curcumin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: April 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sulindac
    Sulindac 150 mg po BID
    Drug: curcumin
    Curcumin 250 mg po BID
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176618

Locations
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Yang CS, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: C. S. Yang, PhD, The Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT00176618     History of Changes
Other Study ID Numbers: 4611, CINJ#120305
Study First Received: September 13, 2005
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
Aberrant Crypt Foci

Additional relevant MeSH terms:
Aberrant Crypt Foci
Neoplasms
Precancerous Conditions

ClinicalTrials.gov processed this record on October 29, 2014