We propose to continue and complete a randomized double-blind clinical trial of the efficacy of beta-carotene in preventing non-melanoma skin cancer in persons at high risk for this condition. This is a collaborative investigation conducted at four clinical centers with a separate data coordinating center. A total of 1805 patients have been entered and randomized to either beta-carotene, 50 mg per day, or placebo. They were identified from records of dermatology services and pathology laboratories at the four participating institutions and each had a proven diagnosis of either basal or squamous cell carcinoma of the skin since January 1, 1980. Each undergoes a total skin examination yearly with biopsy and independent dermatopathological examination of all suspicious lesion. Blood has been drawn for beta-carotene and retinol analyses at study entry and yearly thereafter. Every four months study participants complete a questionnaire providing information on compliance with the drug regimen, possible side effects experienced, and dermatological and non-dermatological conditions occurring in the interval. This application is for the final three years of a projected ten year study. It will allow us to complete five years of follow-up for all subjects and to analyze and report study results.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01CA032934-08
Application #
3548298
Study Section
(SRC)
Project Start
1982-09-30
Project End
1992-08-31
Budget Start
1989-09-08
Budget End
1990-08-31
Support Year
8
Fiscal Year
1989
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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