Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-29 @ 8:23 AM
Study NCT ID:
NCT01111292
Status:
TERMINATED
Last Update Posted:
2016-07-12
First Post:
2010-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed prematurely due to poor accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-01434 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000671302 | None | None | View | |
| NCI09-13-02 | OTHER | Northwestern University | View | |
| NWU09-13-02 | OTHER | DCP | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CN35157 | NIH | None | https://reporter.nih.gov/quic… | View |