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

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