Trial Outcomes & Findings for Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia (NCT NCT01111292)
NCT ID: NCT01111292
Last Updated: 2016-07-12
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline to 90 days
Results posted on
2016-07-12
Participant Flow
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).
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).
Participant milestones
| Measure |
Arm I (Inositol)
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 II (Placebo)
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
|
|---|---|---|
|
Randomization
STARTED
|
3
|
2
|
|
Randomization
COMPLETED
|
3
|
2
|
|
Randomization
NOT COMPLETED
|
0
|
0
|
|
Treatment
STARTED
|
3
|
2
|
|
Treatment
COMPLETED
|
2
|
1
|
|
Treatment
NOT COMPLETED
|
1
|
1
|
|
Post Treatment Biopsy
STARTED
|
2
|
1
|
|
Post Treatment Biopsy
COMPLETED
|
2
|
1
|
|
Post Treatment Biopsy
NOT COMPLETED
|
0
|
0
|
|
Follow-Up
STARTED
|
2
|
1
|
|
Follow-Up
COMPLETED
|
2
|
1
|
|
Follow-Up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Inositol)
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 II (Placebo)
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
|
|---|---|---|
|
Treatment
Physician Decision
|
1
|
1
|
Baseline Characteristics
Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
Baseline characteristics by cohort
| Measure |
Arm I (Inositol)
n=3 Participants
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 II (Placebo)
n=2 Participants
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
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 90 daysPopulation: 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 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.
Outcome measures
| Measure |
Arm I (Inositol)
n=2 Participants
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 II (Placebo)
n=1 Participants
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
|
|---|---|---|
|
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.
Baseline Cells/100 IEC
|
2.5 Colonic Biopsies
Standard Deviation 2.5
|
0 Colonic Biopsies
Standard Deviation 0
|
|
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.
Post Intervention Cells/100 IEC
|
3.67 Colonic Biopsies
Standard Deviation .94
|
0 Colonic Biopsies
|
|
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.
Baseline Crypts w/2 cells
|
7.75 Colonic Biopsies
Standard Deviation 7.85
|
2.5 Colonic Biopsies
Standard Deviation 5
|
|
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.
Post Intervention Crypts w/ 2 cells
|
8.67 Colonic Biopsies
Standard Deviation 2.49
|
0 Colonic Biopsies
Standard Deviation 0
|
|
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.
Baseline Crypts w/3 cells
|
2 Colonic Biopsies
Standard Deviation 1.58
|
.5 Colonic Biopsies
Standard Deviation .5
|
|
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.
Post Intervention Crypts w/ 3 Cells
|
2.67 Colonic Biopsies
Standard Deviation 1.25
|
0 Colonic Biopsies
Standard Deviation 0
|
|
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.
Baseline Crypts w/4 cells
|
2 Colonic Biopsies
Standard Deviation 1.58
|
0 Colonic Biopsies
Standard Deviation 0
|
|
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.
Post Intervention Crypts w/4 cells
|
1.67 Colonic Biopsies
Standard Deviation 1.7
|
0 Colonic Biopsies
Standard Deviation 0
|
|
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.
Baseline Crypts w/>5 cells
|
2.25 Colonic Biopsies
Standard Deviation 2.28
|
0 Colonic Biopsies
Standard Deviation 0
|
|
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.
Post Intervention Crypts w/>5 cells
|
0 Colonic Biopsies
Standard Deviation 0
|
0 Colonic Biopsies
Standard Deviation 0
|
|
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.
Baseline # HF Fields of View
|
2.5 Colonic Biopsies
Standard Deviation 2.3
|
0 Colonic Biopsies
Standard Deviation 0
|
|
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.
Post Intervention # HF Fields
|
2 Colonic Biopsies
Standard Deviation .82
|
0 Colonic Biopsies
Standard Deviation 0
|
Adverse Events
Arm I (Inositol)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Inositol)
n=3 participants at risk
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 II (Placebo)
n=2 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder: Stomach Pain
|
33.3%
1/3 • Number of events 2
|
0.00%
0/2
|
|
Gastrointestinal disorders
Gastrointestinal Disorder: Diarrhea
|
33.3%
1/3 • Number of events 20
|
50.0%
1/2 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorder: Amal Henorrhage: Blood in sttol
|
0.00%
0/3
|
50.0%
1/2 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder: Abdominal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Gastrointestinal disorder: Flatulence
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Gastrointestinal disprder: Hemorroids
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Gastrointestinal Disorder: High Bilirubin
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60