Know Cancer

or
forgot password

Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)


N/A
21 Years
85 Years
Open (Enrolling)
Both
Familial Adenomatous Polyposis

Thank you

Trial Information

Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)


Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or
placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor
questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.


Inclusion Criteria:



- 21-85 years with FAP (with an intact colon or who have had surgery)

Exclusion Criteria:

- Mentally incompetent

- Female patients of childbearing age not on effective birth control

- Patients with WBC < 3,500/ml, platelet count < 100,000/ml, BUN > 25mg%, creatinine >
1.5mg%

- Patients unable to stop NSAIDS or aspirin use for the duration of the study

- Malignancy other than nonmelanoma skin cancer

- Active bacterial infection

- Patients with GERD (Gastro esophageal reflux disease)

- Patients with a history of peptic (stomach or duodenal) ulcer disease

- Patients on Warfarin or anti-platelet drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Marcia R. Cruz-Correa, MD. PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Puerto Rico

Authority:

United States: Food and Drug Administration

Study ID:

Protocol A2210108-UPR

NCT ID:

NCT00927485

Start Date:

November 2007

Completion Date:

November 2016

Related Keywords:

  • Familial Adenomatous Polyposis
  • Familial Adenomatous Polyposis (FAP)
  • Curcumin
  • Colorectal polyps
  • Duodenal polyps
  • Adenoma
  • Adenomatous Polyposis Coli
  • Colorectal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location