This chemoprevention trial tests the efficacy of retinol and beta-carotene in preventing lung cancer in two related high-risk population: (a) heavy smokers recruited from insurance-based sources, and (b) current and former workers with heavy occupational asbestos exposure recruited from workers compensation and employment-based sources. The double-blind two-arm randomized protocol compares placebos with a daily combination of 30mg beta- carotene plus 25,000 IU retinol. We will recruit eligible asbestos-exposed subjects from the [Connecticut] area. We will participate in implementing a cost-effective, well-integrated, multi-clinic strategy, with the Seattle- based coordinating center for project management and data analysis. During the first 3 years of the new grant period (1988-91) we will recruit and enroll [1000] subjects randomized according to the multi-center protocol. We will provide all necessary data to evaluate accrual, coordination, and costs in geographically-bispersed clinic sites to generate best estimates of the remaining needs for the full-scale enrollment and follow-up. Current assumptions and projections indicated that the full-scale efficacy trial will be capable of detecing significant reductions in lung cancer incidence in the high-risk groups combined, and in either subgroup alone, with 13,000 smokers and 4000 asbestos-exposed subjects.
| Redlich, C A; Blaner, W S; Van Bennekum, A M et al. (1998) Effect of supplementation with beta-carotene and vitamin A on lung nutrient levels. Cancer Epidemiol Biomarkers Prev 7:211-4 |
| Redlich, C A; Grauer, J N; Van Bennekum, A M et al. (1996) Characterization of carotenoid, vitamin A, and alpha-tocopheral levels in human lung tissue and pulmonary macrophages. Am J Respir Crit Care Med 154:1436-43 |
