Aspirin/Folate Prevention of Large Bowel Polyps

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ClinicalTrials.gov Identifier: NCT00272324

Recruitment Status : Completed

First Posted : January 5, 2006

Last Update Posted : March 13, 2020

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Dartmouth-Hitchcock Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer Polyps Adenomas	Drug: Aspirin Drug: Folate	Phase 2 Phase 3

Detailed Description:

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 among subjects with a recent history of these tumors. The study is a randomized, double-blind, placebo-controlled trial with a 2 x 3 factorial design.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	1121 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Double
Primary Purpose:	Prevention
Official Title:	Aspirin/Folate Prevention of Large Bowel Polyps
Study Start Date :	February 1992
Study Completion Date :	January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins Folic Acid

Drug Information available for: Aspirin Folic acid Vitamin B Complex

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1 or more adenomas [ Time Frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8 ]
colorectal adenomas detected at follow-up colonoscopy

Secondary Outcome Measures :

number of adenomas [ Time Frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8 ]
colorectal adenomas detected at follow-up colonoscopy
1 or more advanced lesions [ Time Frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8 ]
adenomas measuring at least 1 cm in diameter or with tubulovillous or villous features, severe dysplasia, or invasive cancer

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

One neoplastic polyp removed within three months of study entry or within 16 months of study entry if over 1 cm in size or if subject has had a lifetime history of at least two polyps, with the entire large bowel seen by colonoscopy to be free of further polyps within 3 months of entry.
An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
Age between 21 and 80 years at the time of the intake colonoscopy.
For women of childbearing potential, agreement to use effective birth control for the duration of the study.
Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
Not randomized previously or currently in a chemoprevention trial, except for the: "Nutritional Prevention of Large Bowel Polyps" Study (Polyps Prevention Study I); and brief participation in the "VA Cooperative Study" with no continuing involvement.

Exclusion Criteria:

Invasive carcinoma in any colonic polyp removed.
Familial colonic polyposis syndromes.
Ulcerative colitis or Crohn's disease.
Malabsorption syndrome (e.g. pancreatic insufficiency).
Large bowel resection for any reason.
Diagnosed narcotic or alcohol dependence
Contraindication to aspirin use, including:
1. documented peptic ulcer disease in the past 20 years
2. aspirin sensitivity
3. bleeding diathesis, including hemorrhagic stroke
Likelihood of NSAID use
1. recurring arthritis or other musculo-skeletal problems
2. frequent NSAID use in 5 years preceding
3. history of stroke or TIAs
4. history of angina or myocardial infarction
5. desire to take aspirin for the prevention of cardiovascular disease
Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
Pregnancy or lactation.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272324

Locations

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United States, California
USC/Kaiser
Los Angeles, California, United States
United States, Colorado
University of Colorado
Denver, Colorado, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, Michigan
Henry Ford Health Sciences Center
Detroit, Michigan, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	John A Baron, MD, MSc	Dartmouth-Hitchcock Medical Center

More Information

Publications of 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 A(4) 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.

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ClinicalTrials.gov Identifier:	NCT00272324
Other Study ID Numbers:	5R01CA059005-12 ( U.S. NIH Grant/Contract )
First Posted:	January 5, 2006 Key Record Dates
Last Update Posted:	March 13, 2020
Last Verified:	March 2020

Keywords provided by Dartmouth-Hitchcock Medical Center:


Colorectal neoplasms Adenomatous polyps

Additional relevant MeSH terms:

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Adenoma Polyps Neoplasms Pathological Conditions, Anatomical Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics

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