Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin

A randomized controlled trial

Larry C. Clark, Gerald F. Combs, Bruce W. Turnbull, Elizabeth H. Slate, Dan K. Chalker, James Chow, Loretta S Davis, Renee A. Glover, Gloria F. Graham, Earl G. Gross, Arnon Krongrad, Jack L Lesher, H. Kim Park, Beverly B. Sanders, Cameron L. Smith, J. Richard Taylor

Research output: Contribution to journalArticle

2411 Citations (Scopus)

Abstract

Objective. - To determine whether a nutritional supplement of selenium will decrease the incidence of cancer. Design. - A multicenter, double- blind, randomized, placebo-controlled cancer prevention trial. Setting. - Seven dermatology clinics in the eastern United States. Patients. - A total of 1312 patients (mean age, 63 years; range, 18-80 years) with a history of basal cell or squamous cell carcinomas of the skin were randomized from 1983 through 1991. Patients were treated for a mean (SD) of 4.5 (2.8) years and had a total follow-up of 6.4 (2.0) years. Interventions. - Oral administration of 200 μg of selenium per day or placebo. Main Outcome Measures. - The primary end points for the trial were the incidences of basal and squamous cell carcinomas of the skin. The secondary end points, established in 1990, were all-cause morality and total cancer mortality, total cancer incidence, and the incidences of lung, prostate, and colorectal cancers. Results. - After a total follow-up of 8271 person-years, selenium treatment did not significantly affect the incidence of basal cell or squamous cell skin cancer. There were 377 new cases of basal cell skin cancer among patients in the selenium group and 350 cases among the control group (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28), and 218 new squamous cell skin cancers in the selenium group and 190 cases among the controls (RR, 1.14; 95% CI, 0.93-1.39). Analysis of secondary end points revealed that, compared with controls, patients treated with selenium had a nonsignificant reduction in all-cause mortality (108 deaths in the selenium group and 129 deaths in the control group [RR, 0.83; 95% CI, 0.63-1.08]) and significant reductions in total cancer mortality (29 deaths in the selenium treatment group and 57 deaths in controls [RR, 0.50; 95% CI, 0.31-0.80]), total cancer incidence (77 cancers in the selenium group and 119 in controls [RR, 0.63; 95% CI, 0.47-0.85]), and incidences of lung, colorectal, and prostate cancers. Primarily because of the apparent reductions in total cancer mortality and total cancer incidence in the selenium group, the blinded phase of the trial was stopped early. No cases of selenium toxicity occurred. Conclusions. - Selenium treatment did not protect against development of basal or squamous cell carcinomas of the skin. However, results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites. These effects of selenium require confirmation in an independent trial of appropriate design before new public health recommendations regarding selenium supplementation can be made.

Original languageEnglish (US)
Pages (from-to)1957-1963
Number of pages7
JournalJournal of the American Medical Association
Volume276
Issue number24
StatePublished - Dec 25 1996

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Selenium
Randomized Controlled Trials
Carcinoma
Skin
Neoplasms
Incidence
Confidence Intervals
Skin Neoplasms
Mortality
Squamous Cell Carcinoma
Squamous Cell Neoplasms
Basal Cell Carcinoma
Colorectal Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Basal Cell Neoplasms
Placebos
Control Groups
Dermatology
Oral Administration

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Clark, L. C., Combs, G. F., Turnbull, B. W., Slate, E. H., Chalker, D. K., Chow, J., ... Taylor, J. R. (1996). Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin: A randomized controlled trial. Journal of the American Medical Association, 276(24), 1957-1963.

Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin : A randomized controlled trial. / Clark, Larry C.; Combs, Gerald F.; Turnbull, Bruce W.; Slate, Elizabeth H.; Chalker, Dan K.; Chow, James; Davis, Loretta S; Glover, Renee A.; Graham, Gloria F.; Gross, Earl G.; Krongrad, Arnon; Lesher, Jack L; Park, H. Kim; Sanders, Beverly B.; Smith, Cameron L.; Taylor, J. Richard.

In: Journal of the American Medical Association, Vol. 276, No. 24, 25.12.1996, p. 1957-1963.

Research output: Contribution to journalArticle

Clark, LC, Combs, GF, Turnbull, BW, Slate, EH, Chalker, DK, Chow, J, Davis, LS, Glover, RA, Graham, GF, Gross, EG, Krongrad, A, Lesher, JL, Park, HK, Sanders, BB, Smith, CL & Taylor, JR 1996, 'Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin: A randomized controlled trial', Journal of the American Medical Association, vol. 276, no. 24, pp. 1957-1963.
Clark, Larry C. ; Combs, Gerald F. ; Turnbull, Bruce W. ; Slate, Elizabeth H. ; Chalker, Dan K. ; Chow, James ; Davis, Loretta S ; Glover, Renee A. ; Graham, Gloria F. ; Gross, Earl G. ; Krongrad, Arnon ; Lesher, Jack L ; Park, H. Kim ; Sanders, Beverly B. ; Smith, Cameron L. ; Taylor, J. Richard. / Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin : A randomized controlled trial. In: Journal of the American Medical Association. 1996 ; Vol. 276, No. 24. pp. 1957-1963.
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abstract = "Objective. - To determine whether a nutritional supplement of selenium will decrease the incidence of cancer. Design. - A multicenter, double- blind, randomized, placebo-controlled cancer prevention trial. Setting. - Seven dermatology clinics in the eastern United States. Patients. - A total of 1312 patients (mean age, 63 years; range, 18-80 years) with a history of basal cell or squamous cell carcinomas of the skin were randomized from 1983 through 1991. Patients were treated for a mean (SD) of 4.5 (2.8) years and had a total follow-up of 6.4 (2.0) years. Interventions. - Oral administration of 200 μg of selenium per day or placebo. Main Outcome Measures. - The primary end points for the trial were the incidences of basal and squamous cell carcinomas of the skin. The secondary end points, established in 1990, were all-cause morality and total cancer mortality, total cancer incidence, and the incidences of lung, prostate, and colorectal cancers. Results. - After a total follow-up of 8271 person-years, selenium treatment did not significantly affect the incidence of basal cell or squamous cell skin cancer. There were 377 new cases of basal cell skin cancer among patients in the selenium group and 350 cases among the control group (relative risk [RR], 1.10; 95{\%} confidence interval [CI], 0.95-1.28), and 218 new squamous cell skin cancers in the selenium group and 190 cases among the controls (RR, 1.14; 95{\%} CI, 0.93-1.39). Analysis of secondary end points revealed that, compared with controls, patients treated with selenium had a nonsignificant reduction in all-cause mortality (108 deaths in the selenium group and 129 deaths in the control group [RR, 0.83; 95{\%} CI, 0.63-1.08]) and significant reductions in total cancer mortality (29 deaths in the selenium treatment group and 57 deaths in controls [RR, 0.50; 95{\%} CI, 0.31-0.80]), total cancer incidence (77 cancers in the selenium group and 119 in controls [RR, 0.63; 95{\%} CI, 0.47-0.85]), and incidences of lung, colorectal, and prostate cancers. Primarily because of the apparent reductions in total cancer mortality and total cancer incidence in the selenium group, the blinded phase of the trial was stopped early. No cases of selenium toxicity occurred. Conclusions. - Selenium treatment did not protect against development of basal or squamous cell carcinomas of the skin. However, results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites. These effects of selenium require confirmation in an independent trial of appropriate design before new public health recommendations regarding selenium supplementation can be made.",
author = "Clark, {Larry C.} and Combs, {Gerald F.} and Turnbull, {Bruce W.} and Slate, {Elizabeth H.} and Chalker, {Dan K.} and James Chow and Davis, {Loretta S} and Glover, {Renee A.} and Graham, {Gloria F.} and Gross, {Earl G.} and Arnon Krongrad and Lesher, {Jack L} and Park, {H. Kim} and Sanders, {Beverly B.} and Smith, {Cameron L.} and Taylor, {J. Richard}",
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T1 - Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin

T2 - A randomized controlled trial

AU - Clark, Larry C.

AU - Combs, Gerald F.

AU - Turnbull, Bruce W.

AU - Slate, Elizabeth H.

AU - Chalker, Dan K.

AU - Chow, James

AU - Davis, Loretta S

AU - Glover, Renee A.

AU - Graham, Gloria F.

AU - Gross, Earl G.

AU - Krongrad, Arnon

AU - Lesher, Jack L

AU - Park, H. Kim

AU - Sanders, Beverly B.

AU - Smith, Cameron L.

AU - Taylor, J. Richard

PY - 1996/12/25

Y1 - 1996/12/25

N2 - Objective. - To determine whether a nutritional supplement of selenium will decrease the incidence of cancer. Design. - A multicenter, double- blind, randomized, placebo-controlled cancer prevention trial. Setting. - Seven dermatology clinics in the eastern United States. Patients. - A total of 1312 patients (mean age, 63 years; range, 18-80 years) with a history of basal cell or squamous cell carcinomas of the skin were randomized from 1983 through 1991. Patients were treated for a mean (SD) of 4.5 (2.8) years and had a total follow-up of 6.4 (2.0) years. Interventions. - Oral administration of 200 μg of selenium per day or placebo. Main Outcome Measures. - The primary end points for the trial were the incidences of basal and squamous cell carcinomas of the skin. The secondary end points, established in 1990, were all-cause morality and total cancer mortality, total cancer incidence, and the incidences of lung, prostate, and colorectal cancers. Results. - After a total follow-up of 8271 person-years, selenium treatment did not significantly affect the incidence of basal cell or squamous cell skin cancer. There were 377 new cases of basal cell skin cancer among patients in the selenium group and 350 cases among the control group (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28), and 218 new squamous cell skin cancers in the selenium group and 190 cases among the controls (RR, 1.14; 95% CI, 0.93-1.39). Analysis of secondary end points revealed that, compared with controls, patients treated with selenium had a nonsignificant reduction in all-cause mortality (108 deaths in the selenium group and 129 deaths in the control group [RR, 0.83; 95% CI, 0.63-1.08]) and significant reductions in total cancer mortality (29 deaths in the selenium treatment group and 57 deaths in controls [RR, 0.50; 95% CI, 0.31-0.80]), total cancer incidence (77 cancers in the selenium group and 119 in controls [RR, 0.63; 95% CI, 0.47-0.85]), and incidences of lung, colorectal, and prostate cancers. Primarily because of the apparent reductions in total cancer mortality and total cancer incidence in the selenium group, the blinded phase of the trial was stopped early. No cases of selenium toxicity occurred. Conclusions. - Selenium treatment did not protect against development of basal or squamous cell carcinomas of the skin. However, results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites. These effects of selenium require confirmation in an independent trial of appropriate design before new public health recommendations regarding selenium supplementation can be made.

AB - Objective. - To determine whether a nutritional supplement of selenium will decrease the incidence of cancer. Design. - A multicenter, double- blind, randomized, placebo-controlled cancer prevention trial. Setting. - Seven dermatology clinics in the eastern United States. Patients. - A total of 1312 patients (mean age, 63 years; range, 18-80 years) with a history of basal cell or squamous cell carcinomas of the skin were randomized from 1983 through 1991. Patients were treated for a mean (SD) of 4.5 (2.8) years and had a total follow-up of 6.4 (2.0) years. Interventions. - Oral administration of 200 μg of selenium per day or placebo. Main Outcome Measures. - The primary end points for the trial were the incidences of basal and squamous cell carcinomas of the skin. The secondary end points, established in 1990, were all-cause morality and total cancer mortality, total cancer incidence, and the incidences of lung, prostate, and colorectal cancers. Results. - After a total follow-up of 8271 person-years, selenium treatment did not significantly affect the incidence of basal cell or squamous cell skin cancer. There were 377 new cases of basal cell skin cancer among patients in the selenium group and 350 cases among the control group (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28), and 218 new squamous cell skin cancers in the selenium group and 190 cases among the controls (RR, 1.14; 95% CI, 0.93-1.39). Analysis of secondary end points revealed that, compared with controls, patients treated with selenium had a nonsignificant reduction in all-cause mortality (108 deaths in the selenium group and 129 deaths in the control group [RR, 0.83; 95% CI, 0.63-1.08]) and significant reductions in total cancer mortality (29 deaths in the selenium treatment group and 57 deaths in controls [RR, 0.50; 95% CI, 0.31-0.80]), total cancer incidence (77 cancers in the selenium group and 119 in controls [RR, 0.63; 95% CI, 0.47-0.85]), and incidences of lung, colorectal, and prostate cancers. Primarily because of the apparent reductions in total cancer mortality and total cancer incidence in the selenium group, the blinded phase of the trial was stopped early. No cases of selenium toxicity occurred. Conclusions. - Selenium treatment did not protect against development of basal or squamous cell carcinomas of the skin. However, results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites. These effects of selenium require confirmation in an independent trial of appropriate design before new public health recommendations regarding selenium supplementation can be made.

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