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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 2, 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
Enrollment 85
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)
Hide Arm/Group Description 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
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo) Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants 41 participants 85 participants
58.5
(45.0 to 75.0)
58.0
(46.0 to 79.0)
58.0
(45.0 to 79.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 41 participants 85 participants
Female
10
  22.7%
13
  31.7%
23
  27.1%
Male
34
  77.3%
28
  68.3%
62
  72.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 41 participants 85 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  
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
Number Analyzed 44 participants 41 participants 85 participants
27.2
(21.1 to 36.3)
26.0
(21.0 to 35.2)
26.5
(21.0 to 36.3)
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
Number Analyzed 44 participants 41 participants 85 participants
6.0
(1.0 to 14.0)
7.0
(1.0 to 14.0)
7.0
(1.0 to 14.0)
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
1.Primary Outcome
Title 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.
Hide Description

The definitions of responses are:

Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression.

Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Measure Type: Number
Unit of Measure: percentage of participants
Complete response 26.3 13.9
Partial response 10.5 16.7
Stable disease 15.8 36.1
Progressive disease 47.4 33.3
2.Primary Outcome
Title 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.
Hide Description

The definitions of responses are:

Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease

Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Measure Type: Number
Unit of Measure: percentage of participants
Complete response 10.2 7.4
Stable disease 15.9 22.6
Progressive disease 12.5 10.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Generalized estimating equation model on lesions (progressive disease vs. complete response/stable disease) was used to account for intra-patient correlation in the lesion-specific analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Generalized estimating equation model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
0.7 to 3.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment
Hide Description The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Mean (Standard Deviation)
Unit of Measure: percentage change in number of lesions
-53.5  (116.1) -50.0  (115.8)
4.Secondary Outcome
Title Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia
Hide Description [Not Specified]
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: percentage of Ki67 expression level
-22.8  (105.3) -6.2  (98.7)
5.Secondary Outcome
Title Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray
Hide Description [Not Specified]
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected due to a study team decision not to analyze this endpoint.
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-66.96
(-127.56 to 52.26)
-54.32
(-144.65 to 140.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker CC-16 level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
7.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-0.68
(-2.78 to 0.34)
-0.27
(-1.54 to 1.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker IL-6 level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
8.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
-9.25
(-44.32 to 8.62)
9.41
(-52.58 to 54.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker CCL-2 level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
9.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-3.46
(-8.17 to 2.77)
-1.15
(-8.43 to 1.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker MPO level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
10.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-121.47
(-1234.7 to 1122.9)
10.70
(-684.95 to 683.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker CC18 level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
11.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-12.39
(-47.12 to 5.72)
7.21
(-7.62 to 23.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker SFTPD level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
12.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: umol/L
-0.25
(-1.98 to 0.48)
-0.56
(-1.13 to 0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker Total Glutathione level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
13.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-0.08
(-0.82 to 0.92)
-0.58
(-1.71 to 0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker CC-16 level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
14.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
161.18
(-248.55 to 744.31)
-74.11
(-752.24 to 412.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker CRP level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
15.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
0.06
(-0.74 to 0.46)
0.01
(-0.55 to 0.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker IL-6 level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
16.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
2.19
(-35.08 to 29.56)
9.08
(-5.53 to 44.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker CCL-2 level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
17.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
0.20
(-2.05 to 2.17)
0.09
(-1.57 to 4.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker MPO level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
18.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
0.77
(-2.84 to 4.68)
0.88
(-1.7 to 4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker Nitrotyrosine level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
19.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
1.50
(-0.6 to 3.19)
-0.16
(-2.42 to 0.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker CC18 level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
20.Secondary Outcome
Title Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA
Hide Description The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time Frame From baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 38 36
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-0.28
(-0.93 to 1.51)
-0.22
(-1.26 to 2.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Myo-inositol), Arm B (Placebo)
Comments Comparison of the median difference in biomarker SFTPD level between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon Rank-Sum
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
 
Arm/Group Title Arm A (Myo-inositol) Arm B (Placebo)
Hide Arm/Group Description 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.
All-Cause Mortality
Arm A (Myo-inositol) Arm B (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm A (Myo-inositol) Arm B (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/44 (2.27%)      0/41 (0.00%)    
Cardiac disorders     
Cardiac disorder  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV3.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A (Myo-inositol) Arm B (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/44 (81.82%)      32/41 (78.05%)    
Blood and lymphatic system disorders     
Blood disorder  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Cardiac disorders     
Palpitations  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Sinus tachycardia  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Ear and labyrinth disorders     
Middle ear inflammation  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Tinnitus  1  0/44 (0.00%)  0 2/41 (4.88%)  3
Endocrine disorders     
Hypothyroidism  1  0/44 (0.00%)  0 2/41 (4.88%)  2
Eye disorders     
Cataract  1  1/44 (2.27%)  2 0/41 (0.00%)  0
Vitreous hemorrhage  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Gastrointestinal disorders     
Abdominal distension  1  3/44 (6.82%)  5 0/41 (0.00%)  0
Abdominal pain  1  3/44 (6.82%)  5 2/41 (4.88%)  2
Constipation  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Diarrhea  1  18/44 (40.91%)  26 9/41 (21.95%)  14
Dyspepsia  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Dysphagia  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Flatulence  1  13/44 (29.55%)  16 3/41 (7.32%)  5
Gastrointestinal disorder  1  4/44 (9.09%)  5 2/41 (4.88%)  2
Nausea  1  7/44 (15.91%)  7 3/41 (7.32%)  3
Stomach pain  1  0/44 (0.00%)  0 2/41 (4.88%)  2
Tooth disorder  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Vomiting  1  4/44 (9.09%)  6 2/41 (4.88%)  2
General disorders     
Chest pain  1  5/44 (11.36%)  5 0/41 (0.00%)  0
Chills  1  5/44 (11.36%)  5 2/41 (4.88%)  2
Fatigue  1  6/44 (13.64%)  6 7/41 (17.07%)  10
Fever  1  4/44 (9.09%)  4 7/41 (17.07%)  8
General symptom  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Injection site reaction  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Localized edema  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Pain  1  3/44 (6.82%)  3 2/41 (4.88%)  2
Hepatobiliary disorders     
Hepatobiliary disease  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Infections and infestations     
Bladder infection  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Bronchitis  1  0/44 (0.00%)  0 2/41 (4.88%)  2
Peripheral nerve infection  1  0/44 (0.00%)  0 1/41 (2.44%)  2
Pneumonia  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Sinusitis  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Skin infection  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Soft tissue infection  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Upper respiratory infection  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Injury, poisoning and procedural complications     
Bruising  1  2/44 (4.55%)  2 0/41 (0.00%)  0
Fracture  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Investigations     
Laboratory test abnormal  1  2/44 (4.55%)  2 0/41 (0.00%)  0
Platelet count decreased  1  2/44 (4.55%)  2 0/41 (0.00%)  0
Weight gain  1  2/44 (4.55%)  2 0/41 (0.00%)  0
Weight loss  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Metabolism and nutrition disorders     
Anorexia  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Blood glucose increased  1  1/44 (2.27%)  1 1/41 (2.44%)  1
Blood uric acid increased  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Serum sodium decreased  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Back pain  1  1/44 (2.27%)  1 1/41 (2.44%)  1
Bone pain  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Joint disorder  1  1/44 (2.27%)  2 0/41 (0.00%)  0
Joint effusion  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Joint pain  1  2/44 (4.55%)  7 4/41 (9.76%)  5
Joint range of motion decreased cervical spine  1  1/44 (2.27%)  1 1/41 (2.44%)  1
Muscle weakness upper limb  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Musculoskeletal disorder  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Neck pain  1  1/44 (2.27%)  1 1/41 (2.44%)  1
Pain in extremity  1  2/44 (4.55%)  5 2/41 (4.88%)  3
Nervous system disorders     
Dizziness  1  4/44 (9.09%)  4 2/41 (4.88%)  2
Headache  1  1/44 (2.27%)  1 6/41 (14.63%)  6
Memory impairment  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Peripheral sensory neuropathy  1  1/44 (2.27%)  1 1/41 (2.44%)  1
Syncope  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Psychiatric disorders     
Agitation  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Depression  1  1/44 (2.27%)  1 2/41 (4.88%)  3
Insomnia  1  2/44 (4.55%)  2 2/41 (4.88%)  2
Renal and urinary disorders     
Hemoglobin urine positive  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Urinary frequency  1  2/44 (4.55%)  2 1/41 (2.44%)  1
Urogenital disorder  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Reproductive system and breast disorders     
Penile pain  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Prostatic pain  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Reproductive tract disorder  1  1/44 (2.27%)  1 1/41 (2.44%)  1
Testicular pain  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  5/44 (11.36%)  6 3/41 (7.32%)  3
Bronchial obstruction  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Bronchopulmonary hemorrhage  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Bronchospasm  1  2/44 (4.55%)  2 2/41 (4.88%)  3
Cough  1  13/44 (29.55%)  17 13/41 (31.71%)  16
Dyspnea  1  3/44 (6.82%)  4 2/41 (4.88%)  2
Laryngeal edema  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Nasal congestion  1  2/44 (4.55%)  2 5/41 (12.20%)  8
Pharyngolaryngeal pain  1  7/44 (15.91%)  7 7/41 (17.07%)  8
Respiratory disorder  1  2/44 (4.55%)  2 6/41 (14.63%)  9
Voice alteration  1  1/44 (2.27%)  1 2/41 (4.88%)  2
Skin and subcutaneous tissue disorders     
Dry skin  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Pruritus  1  1/44 (2.27%)  1 3/41 (7.32%)  3
Rash desquamating  1  1/44 (2.27%)  1 3/41 (7.32%)  3
Skin disorder  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Skin ulceration  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Sweating  1  2/44 (4.55%)  3 2/41 (4.88%)  2
Vascular disorders     
Hematoma  1  1/44 (2.27%)  1 0/41 (0.00%)  0
Hemorrhage  1  0/44 (0.00%)  0 1/41 (2.44%)  1
Hot flashes  1  1/44 (2.27%)  1 1/41 (2.44%)  1
Hypertension  1  1/44 (2.27%)  1 1/41 (2.44%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV3.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul J. Limburg, M.D., M.P.H.
Organization: Mayo Clinic Rochester
Phone: 507-284-2511
EMail: limburg.paul@mayo.edu
Layout table for additonal information
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