Curcumin Biomarkers

This study has been completed.
Sponsor:
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
  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:

  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.
  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 April 17, 2014