Skip to main content
OpenTrials
Completed

NCT Number: NCT01333917

Curcumin Biomarkers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UNC Department of Family Medicine

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Curcumin C3 tablet

Drug

4 grams Curcumin C3 tablet daily x30 days

Primary outcomes

  1. Gene expression

    Time frame: 30 days

    Change in gene expression

  2. Ribonucleic acid (RNA) level

    Time frame: 30 days

    Transcript level as mRNA copies per cell

  3. Apoptosis

    Time frame: 30 days

    Immunohistochemistry (IHC) signal as intensity and proportion of cells stained

Secondary outcomes

  1. Number of Participants with Adverse Events

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Curcumin Chemoprevention of Colorectal Neoplasia

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Apr 12, 2011
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.