Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

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Colitis

Colitis, Ulcerative

Ulcer

Hyperplasia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

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Micronutrients

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Other Dietary Supplements

Vitamins

Inositol

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.

Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.

Placebo

Seema Khan

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.

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.

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

Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia

The primary objective of this study will be to evaluate the effect of myo-inositol (inositol), administered for three months, on P-β-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.

National Cancer Institute (NCI)

Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.

Inositol: Given PO

Laboratory Biomarker Analysis: Correlative studies

Arm I (Inositol)

Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.

Placebo: Given PO

Laboratory Biomarker Analysis: Correlative studies

Arm II (Placebo)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Seema Khan

Baseline Cells/100 IEC

Post Intervention Cells/100 IEC

Baseline Crypts w/2 cells

Post Intervention Crypts w/ 2 cells

Baseline Crypts w/3 cells

Post Intervention Crypts w/ 3 Cells

Baseline Crypts w/4 cells

Post Intervention Crypts w/4 cells

Baseline Crypts w/>5 cells

Post Intervention Crypts w/>5 cells

Baseline # HF Fields of View

Post Intervention # HF Fields

pβ-cat-positive cell counts in pre- and post-study biopsies with dysplasia or adenoma. Counts are broken down as the number of crypts with 3, 4, or 5 pβ-cat positive cells. High frequency (HF) fields of view are those containing at least 2 crypts with three or more pβ-cat positive cells per crypt (at 20X). I

The Effect of Myo-inositol (Inositol) on P-β-catenin Staining in Areas of Low Grade Dysplasia in Subjects With Known Colitis-induced Low Grade Dysplasia.

Randomization

Treatment

Post Treatment Biopsy

Follow-Up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia	NCT01111292	Colon Carcinoma Dysplasia in Cr... Low Grade Dyspl... Rectal Carcinom...	Inositol Placebo	18 Years -	National Cancer Institute (NCI)
Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia	NCT01111292	Colon Carcinoma Dysplasia in Cr... Low Grade Dyspl... Rectal Carcinom...	Inositol Placebo	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for low grade dysplasia in ulcerative colitis