Curcumin in Treating Patients With Familial Adenomatous Polyposis

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Familial Adenomatous Polyposis

Treatments: Drug: Curcumin; Other: Laboratory Biomarker Analysis; Other: Placebo

Study type: Interventional

Funder types: NIH

Identifiers

NCT00641147

CDR0000592794 (Other Identifier)

NCI-2013-00536 (Other Identifier)

P30CA006973 (U.S. NIH Grant/Contract)

NA_00011821 (Other Identifier)

R01CA134620 (U.S. NIH Grant/Contract)

1R01CA134620 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Specific Aims:

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Arm I (curcumin)

Experimental group

Description:

Patients receive curcumin PO BID for 12 months. Laboratory Biomarker Analysis

Treatment:

Other: Laboratory Biomarker Analysis

Drug: Curcumin

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO BID for 12 months. Laboratory Biomarker Analysis

Treatment:

Other: Placebo

Other: Laboratory Biomarker Analysis