ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00783705
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : August 25, 2015
Last Update Posted : December 5, 2017
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: Non-small Cell Lung Cancer
Squamous Lung Dysplasia
Interventions: Other: placebo
Drug: inositol

  Participant Flow

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

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 
Overall Participants Analyzed 
[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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      10  22.7%      13  31.7%      23  27.1% 
Male      34  77.3%      28  68.3%      62  72.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2   4.5%      3   7.3%      5   5.9% 
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      42  95.5%      38  92.7%      80  94.1% 
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 
[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

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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

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

5.  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 ]
  Show Outcome Measure 5

6.  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 ]
  Show Outcome Measure 6

7.  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 ]
  Show Outcome Measure 7

8.  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 ]
  Show Outcome Measure 8

9.  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 ]
  Show Outcome Measure 9

10.  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 ]
  Show Outcome Measure 10

11.  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 ]
  Show Outcome Measure 11

12.  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 ]
  Show Outcome Measure 12

13.  Secondary:   Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]
  Show Outcome Measure 13

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

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

16.  Secondary:   Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]
  Show Outcome Measure 16

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

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

19.  Secondary:   Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]
  Show Outcome Measure 19

20.  Secondary:   Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA   [ Time Frame: From baseline up to 6 months ]
  Show Outcome Measure 20


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00783705     History of Changes
Other Study ID Numbers: NCI-2009-00839
NCI-2009-00839 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000617846
MAY06-8-01 ( Other Identifier: Mayo Clinic )
MAY06-8-01 ( Other Identifier: DCP )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: October 31, 2008
First Posted: November 3, 2008
Results First Submitted: April 29, 2015
Results First Posted: August 25, 2015
Last Update Posted: December 5, 2017