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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
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Colon Carcinoma
Dysplasia in Crohn Disease
Low Grade Dysplasia in Ulcerative Colitis
Rectal Carcinoma
Interventions Drug: Inositol
Other: Placebo
Enrollment 5
Recruitment Details A total of 73 patients were screened for study eligibility. Of those, 68 patients were ineligible (no biopsies were taken from 5 patients and 63 did not have a diagnosis of dysplasia at the initial visit).
Pre-assignment Details Serum myo-inositol levels were measured from 13 patients who were screened for study eligibility, and those levels (23.28+/-6.46 μM) were consistent with previously published data (Chiu et al, Dolhofer et al, Lewin et al).
Arm/Group Title Arm I (Inositol) Arm II (Placebo)
Hide Arm/Group Description

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

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

Period Title: Randomization
Started 3 2
Completed 3 2
Not Completed 0 0
Period Title: Treatment
Started 3 2
Completed 2 1
Not Completed 1 1
Reason Not Completed
Physician Decision             1             1
Period Title: Post Treatment Biopsy
Started 2 1
Completed 2 1
Not Completed 0 0
Period Title: Follow-Up
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Arm I (Inositol) Arm II (Placebo) Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
2
 100.0%
2
  40.0%
>=65 years
3
 100.0%
0
   0.0%
3
  60.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
1
  33.3%
0
   0.0%
1
  20.0%
Male
2
  66.7%
2
 100.0%
4
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
2
 100.0%
5
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
2
 100.0%
5
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 2 participants 5 participants
3 2 5
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline to 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Arm I (Inositol) Arm II (Placebo)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 2 1
Mean (Standard Deviation)
Unit of Measure: Colonic Biopsies
Baseline Cells/100 IEC 2.5  (2.5) 0  (0)
Post Intervention Cells/100 IEC 3.67  (.94) 0
Baseline Crypts w/2 cells 7.75  (7.85) 2.5  (5)
Post Intervention Crypts w/ 2 cells 8.67  (2.49) 0  (0)
Baseline Crypts w/3 cells 2  (1.58) .5  (.5)
Post Intervention Crypts w/ 3 Cells 2.67  (1.25) 0  (0)
Baseline Crypts w/4 cells 2  (1.58) 0  (0)
Post Intervention Crypts w/4 cells 1.67  (1.7) 0  (0)
Baseline Crypts w/>5 cells 2.25  (2.28) 0  (0)
Post Intervention Crypts w/>5 cells 0  (0) 0  (0)
Baseline # HF Fields of View 2.5  (2.3) 0  (0)
Post Intervention # HF Fields 2  (.82) 0  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Inositol) Arm II (Placebo)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I (Inositol) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Inositol) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Inositol) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      1/2 (50.00%)    
Gastrointestinal disorders     
Gastrointestinal disorder: Stomach Pain * 1  1/3 (33.33%)  2 0/2 (0.00%)  0
Gastrointestinal Disorder: Diarrhea * 1  1/3 (33.33%)  20 1/2 (50.00%)  3
Gastrointestinal disorder: Amal Henorrhage: Blood in sttol * 1  0/3 (0.00%)  0 1/2 (50.00%)  3
Gastrointestinal disorders - other * 1  0/3 (0.00%)  0 1/2 (50.00%)  1
Gastrointestinal disorder: Abdominal pain * 1  1/3 (33.33%)  1 0/2 (0.00%)  0
Gastrointestinal disorder: Flatulence * 1  1/3 (33.33%)  1 0/2 (0.00%)  0
Gastrointestinal disprder: Hemorroids * 1  1/3 (33.33%)  1 0/2 (0.00%)  0
Investigations     
Gastrointestinal Disorder: High Bilirubin * 1 [1]  1/3 (33.33%)  1 0/2 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.0
[1]
Blood bilirubin increased
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Seema Khan
Organization: Northwestern University
Phone: (312) 503-4236
EMail: SKhan@nm.org
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01111292     History of Changes
Other Study ID Numbers: NCI-2011-01434
NCI-2011-01434 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000671302
NCI09-13-02 ( Other Identifier: Northwestern University )
NWU09-13-02 ( Other Identifier: DCP )
P30CA060553 ( U.S. NIH Grant/Contract )
N01CN35157 ( U.S. NIH Grant/Contract )
First Submitted: April 24, 2010
First Posted: April 27, 2010
Results First Submitted: January 29, 2016
Results First Posted: July 12, 2016
Last Update Posted: July 12, 2016