Effect of Selenium and Vitamin E on Risk of Prostate Cancer and Other Cancers: The Selenium and Vitamin E Cancer Prevention Trial (SELECT)
By S. Lippman, Eric A. Klein, P. Goodman, M. Lucia, I. Thompson, L. Ford, H. Parnes, L. Minasian, J. M. Gaziano, J. Hartline and 23 more. Journal of the American Medical Association (JAMA), 2008
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Context Secondary analyses of two randomized controlled trials (RCTs) and supportive epidemiologic and preclinical indicated the potential of selenium and vitamin E for preventing prostate cancer. Objective To determine whether selenium or vitamin E or both could prevent prostate cancer with little or no toxicity in relatively healthy men. Design, Setting, and Participants Randomization of a planned 32,400 men to selenium, vitamin E, selenium plus vitamin E, and placebo in a double-blinded fashion. Participants were recruited and followed in community practices, local hospitals and HMOs, and tertiary cancer centers in the United States, Canada and Puerto Rico. Baseline eligibility included 50 years or older (African American) or 55 years or older (all others), a serum prostate-specific antigen (PSA) ≤ 4 ng/mL, and a digital rectal examination (DRE) not suspicious for prostate cancer. Between 2001 and 2004, 35,533 men (10% more than planned because of a faster-than-expected accrual rate) were randomly assigned to the four study arms, which were well balanced with respect to all potentially important risk factors. Interventions Oral selenium (200 µg/day from L-selenomethionine) and matched vitamin E placebo, vitamin E (400 IU/day of all rac-α-tocopheryl acetate) and matched selenium placebo, or the two combined or placebo plus placebo for a planned minimum of 7 and maximum of 12 years. Main Outcome Measures Prostate cancer (as determined by routine community diagnostic standards) and prespecified secondary outcomes including lung, colorectal and overall cancer. Results Study supplements were discontinued at the recommendation of the Data and Safety Monitoring Committee at a planned 7-year interim analysis because the evidence convincingly demonstrated no benefit from either study agent (p < 0.0001) and no possibility of a benefit to the planned degree with additional follow-up. As of October 23, 2008, median overall follow-up was 5.46 years (range, 4.17 and 7.33). Hazard ratios (number of prostate cancers, 99% confidence intervals [CIs]) for prostate cancer were 1.13 for vitamin E (n=473; CI, 0.91–1.41), 1.04 for selenium (n=432; CI, 0.83–1.30), and 1.05 for the combination (n=437; CI, 0.83–1.31) compared with placebo (n=416). There were no significant differences (all p-values > 0.15) in any prespecified cancer endpoints. There were nonsignificant increased risks of prostate cancer in the vitamin E arm (p=0.06; relative risk [RR]=1.13; 99% CI, 0l95–1.35) and of Type 2 diabetes mellitus in the selenium arm (p=0.16; RR=1.07; 99% CI, 0.94–1.22), but they were not observed in the combination arm. Conclusion Selenium or vitamin E, alone or in combination, did not prevent prostate cancer in this population at the doses and formulations used.
Subfields: Biochemistry, Nutrition and Dietetics, Pulmonary and Respiratory Medicine
View Paper: https://www.semanticscholar.org/paper/3119eafdfba4ab8cf539a4548ac27a89ca41c990
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Citations in the corpus
- Nutrition and physical activity guidelines for cancer survivors (2012, background): “Likewise, although selenium supplements reduced prostate cancer incidence in a small trial intended to prevent skin cancers,(259,279) the same recently published trial (SELECT) found no protection from selenium in prostate cancer, and it actually predisposed men to diabetes.(278) Two large cohort st”
- Several lines of antioxidant defense against oxidative stress: antioxidant enzymes, nanomaterials with multiple enzyme-mimicking activities, and low-molecular-weight antioxidants (2024, background): “Several studies revealed the beneficial effect of selenium supplementation in terms of reducing cancer risk; however, beneficial effects have been observed only in some individuals and only in some studies (Lippman et al. 2009).”
- Vitamins C and E: Beneficial effects from a mechanistic perspective (2011, result): “In contrast, studies in healthy physicians have shown no benefit of vitamin E supplements with regard to heart disease [77] or cancer, specifically prostate cancer [207].”
- American Cancer Society guidelines on nutrition and physical activity for cancer prevention (2002, background): “However, selenium supplements had no beneficial effect on prostate cancer incidence in a randomized trial designed specifically to test that hypothesis.(120) There is thus no convincing evidence that selenium supplements reduce cancer risk.”
- The Role of Selenium in Inflammation and Immunity: From Molecular Mechanisms to Therapeutic Opportunities (2012, background): “SELECT was one of the largest human cancer prevention trials ever undertaken, but was discontinued well before the planned 12 year intervention period had been completed.”
- Epidemiology of Prostate Cancer (2019, background): “In another large clinical trial (SELECT trial), vitamin E supplementation did not show any benefit in 31,000 men with incident prostate cancer [140].”
- Selenium and selenocysteine: roles in cancer, health and development (2014, background): “, see [8,9]), and the largest cancer prevention trial ever undertaken was terminated early [8].”
- Selenoproteins: molecular pathways and physiological roles. (2014, result): “In accordance with these observations, the results of several clinical trials that investigated the chemopreventive effects of dietary Se supplementation revealed that increased intake of Se above the nutrient requirements may raise the risk of type 2 diabetes mellitus in humans (222, 327).”