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CompletedNCT00783705Updated Dec 5, 2017Results posted

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

A Phase 2 interventional study of placebo and inositol in Non-small Cell Lung Cancer and Squamous Lung Dysplasia, sponsored by National Cancer Institute (NCI). Completed at 4 sites in 2 countries. Open to participants aged 45 Years to 79 Years. Per ClinicalTrials.gov, last updated 2017-12-05.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
45 Years to 79 Years
Sex
All
01

Study summary

This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. It is not yet known whether inositol is more effective than a placebo in preventing lung cancer in smokers with bronchial dysplasia.

Read the detailed description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of myo-inositol (inositol) 9 grams by mouth twice a day for 6 months versus placebo to revert bronchial dysplasia in current/former smokers with or without curatively treated Stage 0/I non-small cell lung cancer.

SECONDARY OBJECTIVES:

I. To further define the mechanism(s) of action of pharmacological doses of myo-inositol as a lung cancer chemopreventive agent by evaluating changes in: the number of dysplastic lesions, Ki-67, caspase-3, peroxisome proliferator-activated receptor (PPAR) gamma, cyclin D1, cyclin E and vascular endothelial growth factor (VEGF) immunostaining in bronchial biopsies; gene expression analysis of ribonucleic acid (RNA) from bronchial brush cells; and changes in inflammatory biomarkers (C-reactive protein [CRP], monocyte chemotactic protein-1 [MCP-1], myeloid progenitor inhibitory factor-1 [MPIF-1] and L-Selectin) levels in bronchoalveolar lavage (BAL) and plasma before and after treatment.

II. To collect additional safety and adverse event profiles of participants enrolled in both intervention arms. III. To establish a biospecimen repository archive for future correlative studies.

OUTLINE: Patients are stratified according to smoking status (current vs former), prior lung cancer (yes vs no), and number of dysplastic lesions at baseline (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.

ARM I: 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 II: Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.

Patients undergo white light and autofluorescence bronchoscopy with bronchoalveolar lavage, bronchial brushings, and biopsies as well as optical coherence tomography imaging and blood sample collection at baseline and after completion of study treatment. Samples are analyzed for tissue biomarkers (e.g., PPAR gamma, Ki-67, caspase-3, cyclin D1, cyclin E, and VEGF) by immunohistochemistry (IHC); cytokine levels (e.g., CRP, MCP-1, MPIF-1, and L-selectin) by ELISA; and gene expression profiles of RNA by microarray.

After completion of study treatment, patients are followed within 30 days.

02

Conditions studied

  • Non-small Cell Lung Cancer
  • Squamous Lung Dysplasia

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 85 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Histologically confirmed bronchial dysplasia in ≥ 1 site AND meets one of the following criteria:

    • Current or former smoker with ≥ a 30 pack-year smoking history and no history of lung cancer

    • Stage 0 or I non-small cell lung cancer (NSCLC) curatively treated by surgery (local ablation or resection), adjuvant chemotherapy, or radiotherapy with a ≥ 30 pack-year smoking history

      • At least 6 months since prior surgery, adjuvant chemotherapy, or radiotherapy

  • No current evidence of lung cancer by CT scan

    • No non-calcified lung nodules ≥ 10 mm diameter on spiral CT scan unless cancer is ruled out by PET/CT scan or by biopsy
  • ECOG performance status 0-1
  • Hemoglobin normal
  • Leukocyte count ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 1.5 times ULN
  • ALT and AST ≤ 1.5 times ULN
  • BUN ≤ 1.5 times ULN
  • Chloride ≤ 1.5 times ULN
  • Total CO_2 ≤ 1.5 times ULN
  • Sodium ≤ 1.5 times ULN
  • Calcium ≤ 1.5 times ULN
  • Potassium ≤ 1.5 times ULN
  • Phosphorus ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30mL/min
  • Fasting blood glucose normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No cancer within the past 3 years except stage 0 or I NSCLC, nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was treated > 6 months ago

  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Severe chronic obstructive pulmonary disease requiring supplemental oxygen
    • Uncontrolled hypertension
    • Psychiatric illness or social situation that would limit compliance with study requirements
  • No schizophrenia or bipolar disorder
  • No diabetes
  • No requirement for supplemental oxygen (continuous or intermittent)
  • SaO_2 ≥ 90% on room air
  • No history of allergic reactions attributed to inositol
  • No history of allergies to any ingredient in the study agent or placebo
  • No other concurrent investigational agents
  • At least 7 days since prior anticoagulant use (e.g., coumadin or heparin)
  • More than 6 months since prior participation in another chemoprevention clinical trial
  • No prior pneumonectomy
  • No prior solid organ transplantation
  • No concurrent lithium, carbamazepine, or valproate
  • No concurrent use of other natural health products containing inositol
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Arm I (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.

    Drug: inositol

  • Experimental
    Arm II (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.

    Other: placebo

Interventions

  • Otherplacebo

    Given orally

    Also known as: PLCB

  • Druginositol

    Given orally

    Also known as: myo-inositol

06

What researchers measure

Primary outcomes

  1. 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.

    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

  2. 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.

    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

Secondary outcomes

  1. Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment

    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

  2. Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia

    Time frame: From baseline up to 6 months

  3. Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray

    Time frame: From baseline up to 6 months

  4. Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    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

  5. Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    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

  6. Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    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

  7. Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    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

  8. Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    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

  9. Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    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

  10. Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

    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

  11. Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA

    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

  12. Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA

    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

  13. Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA

    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

  14. Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA

    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

  15. Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA

    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

  16. Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA

    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

  17. Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA

    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

  18. Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA

    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

07

Results

Posted Aug 25, 2015

Participant flow

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

Participant flow — Overall Study
MilestoneArm A (Myo-inositol)Arm B (Placebo)
Started4441
Completed3836
Not completed65
Withdrew: Adverse event20
Withdrew: Withdrawal by subject32
Withdrew: Lost to follow-up13

Outcome measures

PrimaryPercentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.

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
Reported as:
Number · percentage of participants
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.
percentage of participantsArm A (Myo-inositol)Arm B (Placebo)
Complete response26.313.9
Partial response10.516.7
Stable disease15.836.1
Progressive disease47.433.3
PrimaryPercentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.

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
Reported as:
Number · percentage of participants
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.
percentage of participantsArm A (Myo-inositol)Arm B (Placebo)
Complete response10.27.4
Stable disease15.922.6
Progressive disease12.510.3
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Generalized estimating equation model · p = 0.39 · Odds ratio (or): 1.4 · 95% CI 0.7 to 3.0
SecondaryPercent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment

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
Reported as:
Mean · percentage change in number of lesions
Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment
percentage change in number of lesionsArm A (Myo-inositol)Arm B (Placebo)
Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment-53.5 ± 116.1-50.0 ± 115.8
SecondaryMean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia
Time frame:
From baseline up to 6 months
Reported as:
Mean · percentage of Ki67 expression level
Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia
percentage of Ki67 expression levelArm A (Myo-inositol)Arm B (Placebo)
Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia-22.8 ± 105.3-6.2 ± 98.7
SecondaryChange in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray
Time frame:
From baseline up to 6 months

No measurements were reported for this outcome.

SecondaryChange in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)-66.96 (-127.56 to 52.26)-54.32 (-144.65 to 140.84)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.10
SecondaryChange in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

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
Reported as:
Median · pg/mL
Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
pg/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)-0.68 (-2.78 to 0.34)-0.27 (-1.54 to 1.89)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.03
SecondaryChange in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

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
Reported as:
Median · pg/mL
Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
pg/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)-9.25 (-44.32 to 8.62)9.41 (-52.58 to 54.6)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.58
SecondaryChange in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)-3.46 (-8.17 to 2.77)-1.15 (-8.43 to 1.21)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.06
SecondaryChange in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)-121.47 (-1234.7 to 1122.9)10.70 (-684.95 to 683.25)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.63
SecondaryChange in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)-12.39 (-47.12 to 5.72)7.21 (-7.62 to 23.79)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.22
SecondaryChange in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)

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
Reported as:
Median · umol/L
Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
umol/LArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)-0.25 (-1.98 to 0.48)-0.56 (-1.13 to 0.33)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.06
SecondaryChange in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA-0.08 (-0.82 to 0.92)-0.58 (-1.71 to 0.19)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.35
SecondaryChange in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA161.18 (-248.55 to 744.31)-74.11 (-752.24 to 412.33)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.80
SecondaryChange in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA

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
Reported as:
Median · pg/mL
Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA
pg/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA0.06 (-0.74 to 0.46)0.01 (-0.55 to 0.73)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.22
SecondaryChange in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA

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
Reported as:
Median · pg/mL
Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA
pg/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA2.19 (-35.08 to 29.56)9.08 (-5.53 to 44.08)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.74
SecondaryChange in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA0.20 (-2.05 to 2.17)0.09 (-1.57 to 4.42)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.55
SecondaryChange in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA

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
Reported as:
Median · mmol/L
Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA
mmol/LArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA0.77 (-2.84 to 4.68)0.88 (-1.7 to 4)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.91
SecondaryChange in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA1.50 (-0.6 to 3.19)-0.16 (-2.42 to 0.88)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.46
SecondaryChange in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA

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
Reported as:
Median · ng/mL
Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA
ng/mLArm A (Myo-inositol)Arm B (Placebo)
Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA-0.28 (-0.93 to 1.51)-0.22 (-1.26 to 2.22)
Statistical analysis
  • Arm A (Myo-inositol) vs Arm B (Placebo) · Wilcoxon Rank-Sum · p = 0.52

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A (Myo-inositol)—1/44 (2.3%)36/44 (81.8%)
Arm B (Placebo)—0/41 (0%)32/41 (78%)
Most frequent serious events
Most frequent serious events
EventArm A (Myo-inositol)Arm B (Placebo)
Cardiac disorderCardiac disorders1/440/41
Most frequent other events
Showing 10 of 94
Most frequent other events
EventArm A (Myo-inositol)Arm B (Placebo)
DiarrheaGastrointestinal disorders18/449/41
CoughRespiratory, thoracic and mediastinal disorders13/4413/41
FlatulenceGastrointestinal disorders13/443/41
FatigueGeneral disorders6/447/41
FeverGeneral disorders4/447/41
Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders7/447/41
NauseaGastrointestinal disorders7/443/41
HeadacheNervous system disorders1/446/41
Respiratory disorderRespiratory, thoracic and mediastinal disorders2/446/41
Nasal congestionRespiratory, thoracic and mediastinal disorders2/445/41

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm A (Myo-inositol)Arm B (Placebo)Total
Median58.5 (45.0 to 75.0)58.0 (46.0 to 79.0)58.0 (45.0 to 79.0)
Sex: Female, Male
Sex: Female, Male(Participants)Arm A (Myo-inositol)Arm B (Placebo)Total
Female101323
Male342862
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A (Myo-inositol)Arm B (Placebo)Total
American Indian or Alaska Native000
Asian235
Native Hawaiian or Other Pacific Islander000
Black or African American000
White423880
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Arm A (Myo-inositol)Arm B (Placebo)Total
United States8816
Canada363369
Body Mass Index, kg/m^2
Body Mass Index, kg/m^2(kg/m^2)Arm A (Myo-inositol)Arm B (Placebo)Total
Median27.2 (21.1 to 36.3)26.0 (21.0 to 35.2)26.5 (21.0 to 36.3)
Smoking Status
Smoking Status(participants)Arm A (Myo-inositol)Arm B (Placebo)Total
Current272653
Former171532
Prior NSAID (nonsteroidal anti-inflammatory drugs) Use
Prior NSAID (nonsteroidal anti-inflammatory drugs) Use(participants)Arm A (Myo-inositol)Arm B (Placebo)Total
No282957
Yes161228
Alcohol Intake
Alcohol Intake(participants)Arm A (Myo-inositol)Arm B (Placebo)Total
1 or fewer drinks per day271138
2-3 drinks per day71320
4 or more drinks per day145
None91322

3 further baseline measures are reported on the registry.

08

Study locations

4 sites
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Albuquerque Veterans Administration Medical Center
    Albuquerque, New Mexico 87108-5128, United States
  • BCCA-Vancouver Cancer Centre
    Vancouver, British Columbia V5Z 4E6, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00783705
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 2, 2008
Start date
Nov 2008
Primary completion
May 2014
Completion
May 2014
Results posted
Aug 25, 2015
Last update
Dec 5, 2017

Study contacts

Paul Limburg
principal investigator · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

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