We propose to do a Pilot Study in order to determine the feasibility of a randomized and Double Blind Clinical Trial to test whether increased Beta carotene as a dietary supplement will reduce the risk of Lung Cancer among men aged 55 to 70 who smoke one or more packs of cigarettes daily. The Pilot Study will have three phases: (1) To evaluate the efficacy of 15 to 30 mg of Beta carotene supplementation on serum carotene levels and the possibility of developing obvious carotenemia. (2) To study 400 men randomized into 2 groups: 200 receiving 15 or 30 mg of Beta carotene and 200 Placebo in order to determine the one year changes in serum carotene, lipoprotein and other biochemical parameters. Also, to determine the changes in diet, smoking and alcohol intake, the compliance with pill taking and percentage that will remain in the study. (3) To determine the ability to maintain adherence to protocol for up to two years and to continue to monitor the changes in serum carotene and other biochemical parameters. During the second and third years of the grant, we will begin to plan and organize the recruitment of up to 20,000 men smokers of equal to or greater than one pack of cigarettes per day and 55-70 years of age. The major recruitment will be done in collaboration with the United Steel Workers of America. A plan will be developed to use Local Union and community facilities in Pennsylvania, Ohio and possibly West Virginia as clinical centers for a full-scale Trial. The sample size prepared will make it possible to detect a 33% reduction in Lung Cancer mortality in five years as well as smaller changes in all cancer and total mortality.
