 OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to smoking history active smokers including those who quit within 1 year of diagnosis vs former smokers vs non-smokers, tumor type lung cancer vs head and neck cancer, and stage I vs II for head and neck cancer or T1 vs T2 for lung cancer. Patients are randomized to 1 of 2 treatment arms. 