Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
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ClinicalTrials.gov Identifier: NCT00783705 |
Recruitment Status :
Completed
First Posted : November 2, 2008
Results First Posted : August 25, 2015
Last Update Posted : December 5, 2017
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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Study Type | Interventional |
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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 |
Enrollment | 85 |
Participant Flow
Recruitment Details | 448 subjects were pre-registered through 3 Cancer Prevention Network (CPN) member organizations from 2008 to 2013. |
Pre-assignment Details | 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. |
Arm/Group Title | Arm A (Myo-inositol) | Arm B (Placebo) |
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Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. | Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
Period Title: Overall Study | ||
Started | 44 | 41 |
Completed | 38 | 36 |
Not Completed | 6 | 5 |
Reason Not Completed | ||
Adverse Event | 2 | 0 |
Withdrawal by Subject | 3 | 2 |
Lost to Follow-up | 1 | 3 |
Baseline Characteristics
Arm/Group Title | Arm A (Myo-inositol) | Arm B (Placebo) | Total | |
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Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. | 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 of all reporting groups | |
Overall Number of Baseline Participants | 44 | 41 | 85 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 44 participants | 41 participants | 85 participants | |
58.5
(45.0 to 75.0)
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58.0
(46.0 to 79.0)
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58.0
(45.0 to 79.0)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | 41 participants | 85 participants | |
Female |
10 22.7%
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13 31.7%
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23 27.1%
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Male |
34 77.3%
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28 68.3%
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62 72.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 44 participants | 41 participants | 85 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
2 4.5%
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3 7.3%
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5 5.9%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
42 95.5%
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38 92.7%
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80 94.1%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 44 participants | 41 participants | 85 participants |
United States | 8 | 8 | 16 | |
Canada | 36 | 33 | 69 | |
Body Mass Index, kg/m^2
Median (Full Range) Unit of measure: Kg/m^2 |
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Number Analyzed | 44 participants | 41 participants | 85 participants | |
27.2
(21.1 to 36.3)
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26.0
(21.0 to 35.2)
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26.5
(21.0 to 36.3)
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Smoking Status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 44 participants | 41 participants | 85 participants |
Current | 27 | 26 | 53 | |
Former | 17 | 15 | 32 | |
Prior NSAID (nonsteroidal anti-inflammatory drugs) Use
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 44 participants | 41 participants | 85 participants |
No | 28 | 29 | 57 | |
Yes | 16 | 12 | 28 | |
Alcohol Intake
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 44 participants | 41 participants | 85 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
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 44 participants | 41 participants | 85 participants |
1 Dysplastic lesion | 22 | 19 | 41 | |
>1 Dysplastic lesions | 22 | 22 | 44 | |
Mucosal Biopsies Obtained
Median (Full Range) Unit of measure: Biopsies |
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Number Analyzed | 44 participants | 41 participants | 85 participants | |
6.0
(1.0 to 14.0)
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7.0
(1.0 to 14.0)
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7.0
(1.0 to 14.0)
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Most Advanced Histology
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 44 participants | 41 participants | 85 participants |
Mild dysplasia | 15 | 13 | 28 | |
Moderate dysplasia | 28 | 22 | 50 | |
Severe dysplasia | 1 | 6 | 7 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Paul J. Limburg, M.D., M.P.H. |
Organization: | Mayo Clinic Rochester |
Phone: | 507-284-2511 |
EMail: | limburg.paul@mayo.edu |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00783705 |
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 2, 2008 |
Results First Submitted: | April 29, 2015 |
Results First Posted: | August 25, 2015 |
Last Update Posted: | December 5, 2017 |