The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
This study has been terminated.
(principal Investigator left institution)
Sponsor:
University of Medicine and Dentistry New Jersey
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00176618
First received: September 13, 2005
Last updated: December 10, 2009
Last verified: December 2009
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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 University of Medicine and Dentistry 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:
Detailed Description:
-
Drug: sulindac
Sulindac 150 mg po BID
Drug: curcumin
Curcumin 250 mg po BID
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
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 New Jersey
Investigators
| Principal Investigator: | Yang CS, MD | University of Medicine and Dentistry 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 University of Medicine and Dentistry New Jersey:
|
Aberrant Crypt Foci |
Additional relevant MeSH terms:
|
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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013