Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00783705
First received: October 31, 2008
Last updated: July 28, 2015
Last verified: June 2014
Results First Received: April 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Non-small Cell Lung Cancer
Squamous Lung Dysplasia
Interventions: Other: placebo
Drug: inositol

  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
448 subjects were pre-registered through 3 Cancer Prevention Network (CPN) member organizations from 2008 to 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
363 subjects were excluded from pre-assignment: 342 ineligible via bronchoscopy, 3 participant decision, 13 lab values out of range, 1 screening time line issue and 4 suspicious of cancer.

Reporting Groups
  Description
Arm A (Myo-inositol) Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
Arm B (Placebo) Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.

Participant Flow:   Overall Study
    Arm A (Myo-inositol)     Arm B (Placebo)  
STARTED     44     41  
COMPLETED     38     36  
NOT COMPLETED     6     5  
Adverse Event                 2                 0  
Withdrawal by Subject                 3                 2  
Lost to Follow-up                 1                 3  



  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 A (Myo-inositol) Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
Arm B (Placebo) Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Arm A (Myo-inositol)     Arm B (Placebo)     Total  
Number of Participants  
[units: participants]
  44     41     85  
Age  
[units: years]
Median (Full Range)
  58.5   (45.0 to 75.0)     58.0   (46.0 to 79.0)     58.0   (45.0 to 79.0)  
Gender  
[units: participants]
     
Female     10     13     23  
Male     34     28     62  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     3     5  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     42     38     80  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     8     8     16  
Canada     36     33     69  
Body Mass Index, kg/m^2  
[units: kg/m^2]
Median (Full Range)
  27.2   (21.1 to 36.3)     26.0   (21.0 to 35.2)     26.5   (21.0 to 36.3)  
Smoking Status  
[units: participants]
     
Current     27     26     53  
Former     17     15     32  
Prior NSAID (nonsteroidal anti-inflammatory drugs) Use  
[units: participants]
     
No     28     29     57  
Yes     16     12     28  
Alcohol Intake  
[units: participants]
     
1 or fewer drinks per day     27     11     38  
2-3 drinks per day     7     13     20  
4 or more drinks per day     1     4     5  
None     9     13     22  
Dysplastic Lesions Identified  
[units: participants]
     
1 Dysplastic lesion     22     19     41  
>1 Dysplastic lesions     22     22     44  
Mucosal Biopsies Obtained  
[units: biopsies]
Median (Full Range)
  6.0   (1.0 to 14.0)     7.0   (1.0 to 14.0)     7.0   (1.0 to 14.0)  
Most Advanced Histology  
[units: participants]
     
Mild dysplasia     15     13     28  
Moderate dysplasia     28     22     50  
Severe dysplasia     1     6     7  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.   [ Time Frame: From baseline up to 6 months ]

2.  Primary:   Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.   [ Time Frame: From baseline up to 6 months ]

3.  Secondary:   Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment   [ Time Frame: From baseline up to 6 months ]

4.  Secondary:   Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia   [ Time Frame: From baseline up to 6 months ]

5.  Secondary:   Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)   [ Time Frame: From baseline up to 6 months ]

6.  Secondary:   Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)   [ Time Frame: From baseline up to 6 months ]

7.  Secondary:   Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)   [ Time Frame: From baseline up to 6 months ]

8.  Secondary:   Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)   [ Time Frame: From baseline up to 6 months ]

9.  Secondary:   Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)   [ Time Frame: From baseline up to 6 months ]

10.  Secondary:   Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)   [ Time Frame: From baseline up to 6 months ]

11.  Secondary:   Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)   [ Time Frame: From baseline up to 6 months ]

12.  Secondary:   Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]

13.  Secondary:   Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]

14.  Secondary:   Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]

15.  Secondary:   Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]

16.  Secondary:   Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]

17.  Secondary:   Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]

18.  Secondary:   Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]

19.  Secondary:   Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]

20.  Secondary:   Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray   [ Time Frame: From baseline up to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Paul J. Limburg, M.D., M.P.H.
Organization: Mayo Clinic Rochester
phone: 507-284-2511
e-mail: limburg.paul@mayo.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00783705     History of Changes
Other Study ID Numbers: NCI-2009-00839, NCI-2009-00839, CDR0000617846, MAY06-8-01, MAY06-8-01, P30CA015083
Study First Received: October 31, 2008
Results First Received: April 29, 2015
Last Updated: July 28, 2015
Health Authority: United States: Food and Drug Administration