Curcumin Biomarkers

NCT01333917 | Completed Phase 1

• 1 other identifier: 10-1524
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Curcumin; Colorectal Cancer; GWAS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants with Adverse Events

  30 days

Study Arms (1)

Curcumin

EXPERIMENTAL

4g Curcumin C3 tablet daily

Drug: Curcumin C3 tablet

Interventions

Curcumin C3 tablet DRUG

4 grams Curcumin C3 tablet daily x30 days

Curcumin

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Department of Family Medicine

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Gary N Asher, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 12, 2011
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2013
• Last Updated: February 7, 2013

Record last verified: 2013-01

Locations

US (1)