Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis
- Determine the ability of exisulind to inhibit growth and development of duodenal
adenomas in patients with familial adenomatous polyposis.
- Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when
treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
randomized to one of two treatment arms.
- Arm I: Patients receive oral exisulind 4 times daily.
- Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
James A. DiSario, MD
University of Utah
United States: Federal Government
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|