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

History of Changes

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.
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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 ]

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 ]

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3. Secondary:

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

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4. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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12. Secondary:

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

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13. Secondary:

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

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14. 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 14

15. 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 15

16. Secondary:

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

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17. Secondary:

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

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18. 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 18

19. 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 19

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

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Other Adverse Events

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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
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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	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 ( US NIH Grant/Contract Award Number )
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

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