NCT01111292

Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia

Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot, randomized phase I/II trial studies how well inositol works in preventing colorectal cancer in patients with abnormal cells (dysplasia) associated with inflammation of the colon (colitis). Patients with colitis-associated dysplasia may have an increased risk of developing colorectal cancer. Inositol is a vitamin-like substance that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the effect of myo-inositol (inositol), administered for 3 months, on phospho (P)-beta (B)-catenin staining in areas of low-grade dysplasia or in areas of prior low grade dysplasia in subjects with known colitis-induced low grade dysplasia at baseline. SECONDARY OBJECTIVES: 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 dysplasia. 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 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 mucosal resection. After completion of study treatment, patients are followed up at 2 weeks.

Conditions

• Colon Carcinoma
• Dysplasia in Crohn Disease
• Low Grade Dysplasia in Ulcerative Colitis
• Rectal Carcinoma

Interventions

Type	Name	Description
DRUG	Inositol	Given PO
OTHER	Placebo	Given PO

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2010-04-27
• Last updated: 2016-07-12
• Results posted: 2016-07-12

Locations

3 sites across 1 country: United States