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Curcumin Chemoprevention of Colorectal Neoplasia


Phase 1
40 Years
80 Years
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Curcumin Chemoprevention of Colorectal Neoplasia


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Gene expression

Outcome Description:

Change in gene expression

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Gary N Asher, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Food and Drug Administration

Study ID:

10-1524

NCT ID:

NCT01333917

Start Date:

November 2010

Completion Date:

January 2013

Related Keywords:

  • Colorectal Cancer
  • Curcumin
  • Colorectal Cancer
  • GWAS
  • Colorectal Neoplasms

Name

Location

UNC Department of Family MedicineChapel Hill, North Carolina  27599