Curcumin Biomarkers

Curcumin Chemoprevention of Colorectal Neoplasia

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Curcumin C3 tablet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Department of Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin; 4g Curcumin C3 tablet daily	Drug: Curcumin C3 tablet; 4 grams Curcumin C3 tablet daily x30 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events	30 days

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Gary N Asher, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 11, 2011
• First Posted (Estimate): April 12, 2011

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Curcumin; GWAS
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 10-1524