Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
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|ClinicalTrials.gov Identifier: NCT01111292|
Recruitment Status : Terminated (The study was closed prematurely due to poor accrual.)
First Posted : April 27, 2010
Results First Posted : July 12, 2016
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colon Carcinoma Dysplasia in Crohn Disease Low Grade Dysplasia in Ulcerative Colitis Rectal Carcinoma||Drug: Inositol Other: Placebo||Phase 1 Phase 2|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Arm I (inositol)
Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.
Other Name: myo-Inositol
Placebo Comparator: Arm II (placebo)
Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.
Other Name: PLCB
- 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. [ Time Frame: Baseline to 90 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111292
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|United States, New York|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|Principal Investigator:||Seema Khan||Northwestern University|