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


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

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Trial Information

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


PRIMARY OBJECTIVES:

I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability
and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and
colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients
with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir)
surgery.

II. To measure markers of cell proliferation including colorectal mucosal levels of
ornithine decarboxylase (ODC), polyamines, mucosal DNA methylation, proliferative index
(Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal
prostaglandin, leukotriene levels, and activation of the nuclear factor kappa B (NFKB), and
Akt survival pathways.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.

ARM II: Patients receive placebo PO BID for 12 months.

After completion of study treatment, patients are followed up at 4 months.


Inclusion Criteria:



- Patients with familial adenomatous polyposis who have undergone subtotal colectomy
with ileorectal anastomosis, total coloctomy with ileo-anal pull through (reservoir),
and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or
reservoir

- Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis
without current lower tract adenomatous polyposis i.e. s/p ileostomy

Exclusion Criteria:

- Female patients of childbearing age not on effective birth control

- Pregnant women

- WBC < 3500/ml

- Platelet count < 100,000/ml

- BUN > 25mg%

- Creatinine > 1.5mg%

- Patients unable to stop NSAIDS, aspirin, curcumin, tumeric, calcium, vitamin D, green
tea, or polyphenol E supplements for the duration of the trial

- Malignancy other than nonmelanoma skin cancer

- Active bacterial infection

- Patients with symptoms of active GERD (symptomatic despite medication or current
erosive esophagitis on endoscopy)

- Patients with a history of peptic ulcer disease

- Patients on Warfarin or Plavix

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:

Total number of polyps

Outcome Description:

The average number of polyps in the treatment groups will be compared by the t-test (or a distribution free analog if distribution assumptions are not met). Multivariate regression models will be used to adjust for strongly predictive factors that are not balanced in the treatment groups.

Outcome Time Frame:

Up to 16 months

Safety Issue:

No

Principal Investigator

Francis Giardiello

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2013-00536

NCT ID:

NCT00641147

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Familial Adenomatous Polyposis
  • Adenomatous Polyposis Coli

Name

Location
Johns Hopkins University Baltimore, Maryland  21205