We propose to conduct a randomized, double-blind, placebo controlled clinical trial of the efficacy of beta carotene as a chemopreventive agent for non-melanoma skin cancer. This is a collaborative investigation to be conducted at four study centers with a central data coordinating center. We anticipate a total study population of 1,950. Eligible subjects will be recruited from the four participating institutions by being identified from records of dermatology services and pathology laboratories as having a proven diagnosis by biopsy of either basal or squamous cell carcinoma of the skin during the previous two years or by presenting for treatment of a non-melanoma skin cancer during the first year of the study. The study participants will take either 30 mg. of beta carotene or 30 mg. of placebo every day. Each subject will have a total skin examination yearly with biopsy of all suspicious lesions. Serial sections of all lesions will be reviewed centrally according to a uniform protocol. Blood for carotene and retinol analysis will be drawn on a subset and sent to a central laboratory for analysis. Each year participants will complete a questionnaire providing information on compliance with the drug regimen, possible drug side effects experienced and non-dermatological diseases occurring over the yearly interval.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01CA032934-07
Application #
3548304
Study Section
Epidemiology and Disease Control Subcommittee 3 (EDC)
Project Start
1982-09-30
Project End
1989-08-31
Budget Start
1988-09-01
Budget End
1989-08-31
Support Year
7
Fiscal Year
1988
Total Cost
Indirect Cost
Name
Dartmouth College
Department
Type
Schools of Medicine
DUNS #
041027822
City
Hanover
State
NH
Country
United States
Zip Code
03755
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Karagas, M R; McDonald, J A; Greenberg, E R et al. (1996) Risk of basal cell and squamous cell skin cancers after ionizing radiation therapy. For The Skin Cancer Prevention Study Group. J Natl Cancer Inst 88:1848-53
Greenberg, E R; Baron, J A; Karagas, M R et al. (1996) Mortality associated with low plasma concentration of beta carotene and the effect of oral supplementation. JAMA 275:699-703
Karagas, M R (1994) Occurrence of cutaneous basal cell and squamous cell malignancies among those with a prior history of skin cancer. The Skin Cancer Prevention Study Group. J Invest Dermatol 102:10S-13S
Greenberg, E R (1993) Carotenoids, cigarette smoking, and mortality risk. Ann N Y Acad Sci 691:120-6
Stukel, T A (1993) Comparison of methods for the analysis of longitudinal interval count data. Stat Med 12:1339-51
Karagas, M R; Stukel, T A; Greenberg, E R et al. (1992) Risk of subsequent basal cell carcinoma and squamous cell carcinoma of the skin among patients with prior skin cancer. Skin Cancer Prevention Study Group. JAMA 267:3305-10
Nierenberg, D W; Bayrd, G T; Stukel, T A (1991) Lack of effect of chronic administration of oral beta-carotene on serum cholesterol and triglyceride concentrations. Am J Clin Nutr 53:652-4
Nierenberg, D W; Stukel, T A; Baron, J A et al. (1991) Determinants of increase in plasma concentration of beta-carotene after chronic oral supplementation. The Skin Cancer Prevention Study Group. Am J Clin Nutr 53:1443-9
Greenberg, E R; Baron, J A; Stukel, T A et al. (1990) A clinical trial of beta carotene to prevent basal-cell and squamous-cell cancers of the skin. The Skin Cancer Prevention Study Group. N Engl J Med 323:789-95

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