Curcumin Biomarkers

Colorectal Cancer Clinical Trial

Official title:

Curcumin Chemoprevention of Colorectal Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333917
• Other study ID #: 10-1524
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2011
• Last updated: February 6, 2013
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Curcumin C3 tablet
4 grams Curcumin C3 tablet daily x30 days

Locations

Country	Name	City	State
United States	UNC Department of Family Medicine	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression	Change in gene expression	30 days	No
Primary	Ribonucleic acid (RNA) level	Transcript level as mRNA copies per cell	30 days	No
Primary	Apoptosis	Immunohistochemistry (IHC) signal as intensity and proportion of cells stained	30 days	No
Secondary	Number of Participants with Adverse Events		30 days	Yes