Aspirin/Folate Prevention of Large Bowel Polyps

Summary

This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.

Timeline

Start

1992-02

Primary completion

—

Completion

2007-01

Outcome

Missed primary endpoint

paper Folic acid at 1 mg/d does not reduce colorectal adenoma risk. PMID 17551129 ↗

Publications

• Results Baron JA, Cole BF, Sandler RS, Haile RW, Ahnen D, Bresalier R, McKeown-Eyssen G, Summers RW, Rothstein R, Burke CA, Snover DC, Church TR, Allen JI, Beach M, Beck GJ, Bond JH, Byers T, Greenberg ER, Mandel JS, Marcon N, Mott LA, Pearson L, Saibil F, van Stolk RU. A randomized trial of aspirin to prevent colorectal adenomas. N Engl J Med. 2003 Mar 6;348(10):891-9. doi: 10.1056/NEJMoa021735.
• Figueiredo JC, Passarelli MN, Wei W, Ahnen DJ, Morris JS, Corley L, Mehta T, Bartley AN, McKeown-Eyssen G, Bresalier RS, Barry EL, Goel A, Hernandez Mesa G, Hamilton SR, Baron JA. Proliferation, apoptosis and their regulatory protein expression in colorectal adenomas and serrated lesions. PLoS One. 2021 Nov 11;16(11):e0258878. doi: 10.1371/journal.pone.0258878. eCollection 2021.
• Passarelli MN, Mott LA, Barry EL, Rees JR, Baron JA. Oral Antibiotics and Risk of New Colorectal Adenomas During Surveillance Follow-up. Cancer Epidemiol Biomarkers Prev. 2021 Oct;30(10):1974-1976. doi: 10.1158/1055-9965.EPI-21-0323. Epub 2021 Jul 21.
• Passarelli MN, Barry EL, Rees JR, Mott LA, Zhang D, Ahnen DJ, Bresalier RS, Haile RW, McKeown-Eyssen G, Snover DC, Cole BF, Baron JA. Folic acid supplementation and risk of colorectal neoplasia during long-term follow-up of a randomized clinical trial. Am J Clin Nutr. 2019 Oct 1;110(4):903-911. doi: 10.1093/ajcn/nqz160.
• Passarelli MN, Barry EL, Rees JR, Mott LA, Ahnen DJ, Baron JA. Body Composition and Aspirin Dose for Colorectal Adenoma Prevention in a Randomized Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2019 Jul;28(7):1262-1265. doi: 10.1158/1055-9965.EPI-19-0205.
• Fedirko V, McKeown-Eyssen G, Serhan CN, Barry EL, Sandler RS, Figueiredo JC, Ahnen DJ, Bresalier RS, Robertson DJ, Anderson CW, Baron JA. Plasma lipoxin A4 and resolvin D1 are not associated with reduced adenoma risk in a randomized trial of aspirin to prevent colon adenomas. Mol Carcinog. 2017 Aug;56(8):1977-1983. doi: 10.1002/mc.22629. Epub 2017 Mar 6.
• Yip WK, Bonetti M, Cole BF, Barcella W, Wang XV, Lazar A, Gelber RD. Subpopulation Treatment Effect Pattern Plot (STEPP) analysis for continuous, binary, and count outcomes. Clin Trials. 2016 Aug;13(4):382-90. doi: 10.1177/1740774516643297. Epub 2016 Apr 19.
• Hazra A, Selhub J, Chao WH, Ueland PM, Hunter DJ, Baron JA. Uracil misincorporation into DNA and folic acid supplementation. Am J Clin Nutr. 2010 Jan;91(1):160-5. doi: 10.3945/ajcn.2009.28527. Epub 2009 Nov 18.
• Cole BF, Baron JA, Sandler RS, Haile RW, Ahnen DJ, Bresalier RS, McKeown-Eyssen G, Summers RW, Rothstein RI, Burke CA, Snover DC, Church TR, Allen JI, Robertson DJ, Beck GJ, Bond JH, Byers T, Mandel JS, Mott LA, Pearson LH, Barry EL, Rees JR, Marcon N, Saibil F, Ueland PM, Greenberg ER; Polyp Prevention Study Group. Folic acid for the prevention of colorectal adenomas: a randomized clinical trial. JAMA. 2007 Jun 6;297(21):2351-9. doi: 10.1001/jama.297.21.2351.

Drugs

Indications