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AzTrials

Colorectal CancerPhase 2/3NCT00272324

Aspirin/Folate Prevention of Large Bowel Polyps

A Phase 2/3 study testing Aspirin and Folate in people with Colorectal Cancer and Polyps, run by Dartmouth-Hitchcock Medical Center at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer, Polyps, Adenomas
What is being tested?
Aspirin and Folate
How many people
1,121 participants
Where
9 sitesin 2 countries
Study dates
Feb 1992to Jan 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • Contraindication to aspirin use, including:
  • documented peptic ulcer disease in the past 20 years
  • aspirin sensitivity
  • bleeding diathesis, including hemorrhagic stroke
  • Likelihood of NSAID use
  • recurring arthritis or other musculo-skeletal problems
  • frequent NSAID use in 5 years preceding
  • history of stroke or TIAs
  • history of angina or myocardial infarction
  • 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.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States8 sites

  • University of North Carolina

    Chapel Hill, North Carolina

  • Cleveland Clinic Foundation

    Cleveland, Ohio

  • University of Colorado

    Denver, Colorado

  • Henry Ford Health Sciences Center

    Detroit, Michigan

  • University of Iowa

    Iowa City, Iowa

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • USC/Kaiser

    Los Angeles, California

  • University of Minnesota

    Minneapolis, Minnesota

Other trials in United States

Canada1 site

  • University of Toronto

    Toronto, Ontario

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Aspirin, Folate
Keywords
Colorectal neoplasms, Adenomatous polyps
Medical subject headings
Colorectal Neoplasms, Polyps, Adenoma, Adenomatous Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 or more adenomas

    colorectal adenomas detected at follow-up colonoscopy

    Measured: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8

Secondary outcomes (2)

  1. number of adenomas

    colorectal adenomas detected at follow-up colonoscopy

    Measured: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8

  2. 1 or more advanced lesions

    adenomas measuring at least 1 cm in diameter or with tubulovillous or villous features, severe dysplasia, or invasive cancer

    Measured: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2006 (estimated)
  2. Study startFeb 1992
  3. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
1,121 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00272324
Sponsor's protocol ID
5R01CA059005-12
Status last verified
Mar 2020
First submitted
3 Jan 2006
Last updated
13 Mar 2020
Results posted
No

Publications

  • 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.

    PubMed 12621133

  • 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.

    PubMed 34762658

  • 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.

    PubMed 34289971

  • 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.

    PubMed 31401653

  • 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.

    PubMed 31263057

  • 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.

    PubMed 28218420

  • 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.

    PubMed 27094489

  • 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.

    PubMed 19923375

  • 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.

    PubMed 17551129

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Aspirin and Folate in people with Colorectal Cancer and Polyps, run by Dartmouth-Hitchcock Medical Center at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 or more adenomas (time frame: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00272324, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.

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