Curcumin in Treating Patients With Familial Adenomatous Polyposis

National Cancer Institute (NCI)44 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Familial Adenomatous Polyposis

Interventions

CurcuminDRUG

Given PO

Laboratory Biomarker AnalysisOTHER

Correlative studies

PlaceboOTHER

Given PO

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

University of Puerto Rico

San Juan, Puerto Rico

Outcomes

Primary Outcomes

Polyp Number

Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm

Time frame: Up to 12 months

Secondary Outcomes

Mean Polyp Size in mm

Mean size of the 5 largest polyps

Time frame: Up to 12 months

Number of Participants With a Decrease in Polyp Burden at 12 Months

The polyp burden as evaluated by video tape review. Polyp burden at 12 months compared to time 0 for each participant and counting participants with decrease in polyp burden at 12 months.

Time frame: 12 months

Number of Participants With Grade >=2 Adverse Events

Events were graded as follows: Grade 0= no adverse event or within normal limits; Grade 1= mild adverse event (causing no limitations of usual activity); Grade 2= moderate adverse event (causing some limitation of activity); Grade 3= severe adverse event (severe and undesirable; causing inability to carry out usual activities; Grade 4= life threatening or disabling adverse event; Grade 5= fatal adverse event.

Time frame: Up to 12 months

Medication Compliance

Medication compliance of the participant= number of capsules taken divided by the number of capsules prescribed as determined by pill count and described as a percentage per participant. Then the compliance of each participant in the assigned group (curcumin or placebo) was averaged together to obtain the medication compliance rate of that group.

Time frame: Up to 12 months

Change in Ornithine Decarboxylase (ODC) Activity Levels

Change in ODC mean activity levels (expressed as nmol of activity/mg of mucosal tissue/hr) at 8 months compared to baseline (time 0)

Data from ClinicalTrials.gov

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