Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia
I. To evaluate the effect of myo-inositol (inositol), administered for 3 months, on
P-β-catenin staining in areas of low-grade dysplasia or in areas of prior low grade
dysplasia in patients with colitis-induced low-grade dysplasia.
I. To examine the effect of myo-inositol on regression of dysplasia. II. To examine the
effect of inositol on p53 and Ki67 staining within remaining dysplasia.
III. To examine the effect of inositol on epithelial apoptosis (cleaved caspase-3) within
IV. To examine the effect of inositol on reductions in mucosal messenger ribonucleic acid
(mRNA) levels of monocyte chemotactic protein 1 (MCP1), inducible nitric oxide synthase
(iNOS), and cyclooxygenase (Cox)-2.
OUTLINE: Patients undergo biopsy and colonoscopy to confirm areas of discrete dysplasia.
Patients are randomized to 1 of 2 treatment arms.
ARM I: Beginning within 14 days after colonoscopy, patients receive inositol orally (PO)
once daily (QD) on days 1-14 and twice daily (BID) on days 15-90.
ARM II: Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days
1-14 and BID on days 15-90.
After completion of treatment, patients undergo biopsy and colonoscopy with or without
After completion of study treatment, patients are followed up by telephone at 2 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Change in P-β-catenin staining within areas of dysplasia as measured by immunohistochemistry (IHC) from samples obtained before and after study treatment
P-beta-catenin staining will be measured as percent of positive cells = counted # positively stained cells / total # cells present in the sample under consideration.
Baseline to 90 days
United States: Food and Drug Administration
|Mount Sinai Medical Center||New York, New York 10029|
|Northwestern University||Chicago, Illinois 60611|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|