Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Condition: Non-small Cell Lung Cancer; Squamous Lung Dysplasia
MeSH terms: Lung Neoplasms
Intervention: placebo; inositol
Intervention description: Given orally; Given orally
Intervention MeSH terms: Inositol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 85.0
Sex: All
Minimum age: 45 Years
Maximum age: 79 Years
Healthy volunteers: No

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.
    

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