Entry criteria for the phase I lung cancer chemoprevention trial with leuoselect phytosome
Age over 21.
Smoking history >30 pack years.
Inability to provide informed consent (e.g., cognitive impairment, severe psychiatric disorders).
Hypersensitivity to grapes and related products.
Liver dysfunction (abnormal liver function tests).
Renal dysfunction (abnormal serum creatinine).
End-stage respiratory disease (FEV1 < 0.8 liters, resting or exertional hypoxemia, to select patients with adequate reserve to undergo bronchoscopy andcomplete the study).
Malignancy within 5 years, excluding nonmelanoma type skin cancer or stage I NSCLC postcurative resection without evidence of recurrence.
Systemic corticoid steroid therapy.
Concurrent use of grapes or grape-related products.
Unwilling to refrain from drinking more than 1 glass of wine a day.
Patients with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow-up schedule.
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