Curcumin Biomarkers

February 6, 2013 updated by: University of North Carolina, Chapel Hill

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 30 days
Change in gene expression
30 days
Ribonucleic acid (RNA) level
Time Frame: 30 days
Transcript level as mRNA copies per cell
30 days
Apoptosis
Time Frame: 30 days
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
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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