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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00176618
Recruitment Status : Terminated (principal Investigator left institution)
First Posted : September 15, 2005
Last Update Posted : December 11, 2009
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Aberrant Crypt Foci Drug: sulindac Drug: curcumin Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
Study Start Date : April 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: sulindac
    Sulindac 150 mg po BID
  • Drug: curcumin
    Curcumin 250 mg po BID

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176618


Locations
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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
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Principal Investigator: Yang CS, MD Rutgers, The State University of New Jersey
More Information
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Responsible Party: C. S. Yang, PhD, The Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT00176618    
Other Study ID Numbers: 4611
CINJ#120305
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: December 2009
Keywords provided by Rutgers, The State University of New Jersey:
Aberrant Crypt Foci
Additional relevant MeSH terms:
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Aberrant Crypt Foci
Precancerous Conditions
Neoplasms
Curcumin
Sulindac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors