Clinical Trial: Curcumin in Treating Patients With Familial Adenomatous Polyposis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.

Detailed Summary:

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 deoxyribonucleic acid (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 v-akt murine thymoma viral oncogene homolog 1 (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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Change in activation of NFKB pathway [ Time Frame: Baseline to up to 12 months ]
  • Change in Akt phosphorylation levels [ Time Frame: Baseline to up to 12 months ]
  • Change in apoptosis index levels [ Time Frame: Baseline to up to 12 months ]
  • Change in Ki-67 anti-proliferative cell nuclear antibody index levels [ Time Frame: Baseline to up to 12 months ]
  • Change in mucosa and adenoma histology assessed by light microscopy [ Time Frame: Baseline to up to 12 months ]
  • Change in mucosal DNA methylation levels [ Time Frame: Baseline to up to 12 months ]
  • Change in mucosal leukotriene levels [ Time Frame: Baseline to up to 12 months ]
  • Change in mucosal prostaglandin levels [ Time Frame: Baseline to up to 12 months ]
  • Change in ODC activity levels expressed as nmol of activity/mg of musosal tissue/hr [ Time Frame: Baseline to up to 12 months ]
  • Change in polyamines levels expressed pg/mg protein [ Time Frame: Baseline to up to 12 months ]
  • Change in vascular density [ Time Frame: Baseline to up to 12 months ]
  • Incidence of grade >= 2 adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 12 months ]
    A safety review will be performed at the time of interim analysis.

    Original Primary Outcome: polyp number and size [ Time Frame: 1 year ]

    Current Secondary Outcome:

    Original Secondary Outcome: side effects and medication compliance [ Time Frame: 1 year ]

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: March 17, 2008
    Date Started: October 2010
    Date Completion:
    Last Updated: December 13, 2016
    Last Verified: December 2016