Curcumin Biomarkers
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01333917
First received: April 6, 2011
Last updated: February 6, 2013
Last verified: January 2013
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Purpose
Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Curcumin C3 tablet |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Curcumin Chemoprevention of Colorectal Neoplasia |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Gene expression [ Time Frame: 30 days ] [ Designated as safety issue: No ]Change in gene expression
- Ribonucleic acid (RNA) level [ Time Frame: 30 days ] [ Designated as safety issue: No ]Transcript level as mRNA copies per cell
- Apoptosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]Immunohistochemistry (IHC) signal as intensity and proportion of cells stained
Secondary Outcome Measures:
- Number of Participants with Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | November 2010 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Curcumin
4g Curcumin C3 tablet daily
|
Drug: Curcumin C3 tablet
4 grams Curcumin C3 tablet daily x30 days
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 40 - 80.
- A willingness to follow the study protocol, as indicated by provision of informed consent to participate
- Good general health
Exclusion Criteria:
- Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
- Ulcerative colitis or Crohn's disease.
- History of large bowel resection for any reason
- Diagnosed narcotic or alcohol dependence
- Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals > 3 times a week.
- Allergy to turmeric/curcumin.
- Women with childbearing potential who do not agree to practice effective birth control.
- Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
- Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
- Women who are pregnant or nursing.
- Individuals who have taken antibiotics within the three months prior to enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333917
Locations
| United States, North Carolina | |
| UNC Department of Family Medicine | |
| Chapel Hill, North Carolina, United States, 27599 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | Gary N Asher, MD, MPH | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01333917 History of Changes |
| Other Study ID Numbers: | 10-1524 |
| Study First Received: | April 6, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of North Carolina, Chapel Hill:
|
Curcumin Colorectal Cancer GWAS |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Curcumin 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 |
ClinicalTrials.gov processed this record on June 17, 2013