This chemoprevention trial tests the efficacy of retinol and beta-carotene in preventing lung cancer in two related high-risk populations: (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 30 mg beta-carotene plus 25,000 IU retinol. We will recruit eligible asbestos-exposed subjects from the Baltimore 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 2 years of the new grant period (1988- 91) we will recruit and enroll 800 subjects randomized according to the multi-center protocol. We will provide all necessary data to evaluate accrual, coordination, and costs in geographically-dispersed clinic sites to generate best estimates of the remaining needs for the full-scale enrollment and follow- up. Current assumptions and projections indicate that the full- scale Efficacy Trial will be capable of detecting 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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA048196-01
Application #
3192244
Study Section
(SRC)
Project Start
1988-09-30
Project End
1993-07-31
Budget Start
1988-09-30
Budget End
1989-07-31
Support Year
1
Fiscal Year
1988
Total Cost
Indirect Cost
Name
University of Maryland Baltimore
Department
Type
Schools of Medicine
DUNS #
003255213
City
Baltimore
State
MD
Country
United States
Zip Code
21201