Curcumin Biomarkers

Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Curcumin C3 tablet

• Registration Number: NCT01333917
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Primary Completion: 2011-10
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 40 - 80.
2. A willingness to follow the study protocol, as indicated by provision of informed consent to participate
3. Good general health

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Exclusion Criteria

1. Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
2. Ulcerative colitis or Crohn's disease.
3. History of large bowel resection for any reason
4. Diagnosed narcotic or alcohol dependence
5. Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals > 3 times a week.
6. Allergy to turmeric/curcumin.
7. Women with childbearing potential who do not agree to practice effective birth control.
8. Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
9. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
10. Women who are pregnant or nursing.
11. Individuals who have taken antibiotics within the three months prior to enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Curcumin	Curcumin C3 tablet	4g Curcumin C3 tablet daily

Primary Outcome Measures

Name	Time	Method
Gene expression	30 days	Change in gene expression
Ribonucleic acid (RNA) level	30 days	Transcript level as mRNA copies per cell
Apoptosis	30 days	Immunohistochemistry (IHC) signal as intensity and proportion of cells stained

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	30 days

Trial Locations

Locations (1)

UNC Department of Family Medicine; 🇺🇸 Chapel Hill, North Carolina, United States