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

This study has been terminated.
(The study was closed prematurely due to poor accrual.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01111292
First received: April 24, 2010
Last updated: June 1, 2016
Last verified: June 2016
Results First Received: January 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Colon Carcinoma
Dysplasia in Crohn Disease
Low Grade Dysplasia in Ulcerative Colitis
Rectal Carcinoma
Interventions: Drug: Inositol
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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


Participant Flow for 4 periods

Period 1:   Randomization
    Arm I (Inositol)     Arm II (Placebo)  
STARTED     3     2  
COMPLETED     3     2  
NOT COMPLETED     0     0  

Period 2:   Treatment
    Arm I (Inositol)     Arm II (Placebo)  
STARTED     3     2  
COMPLETED     2     1  
NOT COMPLETED     1     1  
Physician Decision                 1                 1  

Period 3:   Post Treatment Biopsy
    Arm I (Inositol)     Arm II (Placebo)  
STARTED     2     1  
COMPLETED     2     1  
NOT COMPLETED     0     0  

Period 4:   Follow-Up
    Arm I (Inositol)     Arm II (Placebo)  
STARTED     2     1  
COMPLETED     2     1  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Arm I (Inositol)     Arm II (Placebo)     Total  
Number of Participants  
[units: participants]
  3     2     5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     2     2  
>=65 years     3     0     3  
Gender  
[units: participants]
     
Female     1     0     1  
Male     2     2     4  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     3     2     5  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     3     2     5  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     3     2     5  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: 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 ( US NIH Grant/Contract Award Number )
N01CN35157 ( US NIH Grant/Contract Award Number )
Study First Received: April 24, 2010
Results First Received: January 29, 2016
Last Updated: June 1, 2016
Health Authority: United States: Food and Drug Administration