Overview

This trial is active, not recruiting.

Condition familial adenomatous polyposis
Treatments curcumin, laboratory biomarker analysis, placebo
Phase phase 2
Sponsor National Cancer Institute (NCI)
Start date October 2010
End date November 2016
Trial size 50 participants
Trial identifier NCT00641147, 00011821, 1R01CA134620, CDR0000592794, NA_00011821, NCI-2013-00536, P30CA006973, R01CA134620

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Patients receive curcumin PO BID for 12 months.
curcumin C.I. 75300
Given PO
laboratory biomarker analysis
Correlative studies
(Placebo Comparator)
Patients receive placebo PO BID for 12 months.
laboratory biomarker analysis
Correlative studies
placebo placebo therapy
Given PO

Primary Outcomes

Measure
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
Mean polyp size in mm (mean size of the 5 largest polyps)
time frame: Up to 16 months
Medication compliance
time frame: Up to 12 months
Number of patients failing study
time frame: Up to 16 months
Side effects of curcumin treatment
time frame: Up to 12 months
Total number of polyps
time frame: Up to 16 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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. status/post (s/p) ileostomy Exclusion Criteria: - Female patients of childbearing age not on effective birth control - Pregnant women - White blood cell count (WBC) < 3500/ml - Platelet count < 100,000/ml - Blood urea nitrogen (BUN) > 25mg% - Creatinine > 1.5mg% - Patients unable to stop non-steroidal anti-inflammatory drugs (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 gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy) - Patients with a history of peptic ulcer disease - Patients on warfarin or plavix

Additional Information

Official title Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Principal investigator Francis Giardiello
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).