The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
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ClinicalTrials.gov Identifier: NCT00176618 |
Recruitment Status :
Terminated
(principal Investigator left institution)
First Posted : September 15, 2005
Last Update Posted : December 11, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aberrant Crypt Foci | Drug: sulindac Drug: curcumin | Not Applicable |
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 |

- Drug: sulindac
Sulindac 150 mg po BID
- Drug: curcumin
Curcumin 250 mg po BID
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

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
United States, New Jersey | |
Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08901 |
Principal Investigator: | Yang CS, MD | Rutgers, The State University of New Jersey |
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 |
Aberrant Crypt Foci |
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 |