The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
This study has been terminated.
(principal Investigator left institution)
Information provided by:
Rutgers, The State University of New Jersey
First received: September 13, 2005
Last updated: December 10, 2009
Last verified: December 2009
The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon.
Aberrant Crypt Foci
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2007 (Final data collection date for primary outcome measure)
Sulindac 150 mg po BID
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects must be eligible for colorectal cancer (CRC) screening/surveillance by current criteria.
- Subjects must have at least 5 ACF on eligibility chromosigmoidoscopy examination.
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).
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
|Cancer Institute of New Jersey
|New Brunswick, New Jersey, United States, 08901 |
University of Medicine and Dentistry of New Jersey
||Yang CS, MD
||Rutgers, The State University of New Jersey
No publications provided
||C. S. Yang, PhD, The Cancer Institute of New Jersey
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||December 10, 2009
||United States: Food and Drug Administration
Keywords provided by Rutgers, The State University of New Jersey:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 19, 2014
Aberrant Crypt Foci
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents