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Aspirin/Folate Prevention of Large Bowel Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272324
Recruitment Status : Completed
First Posted : January 5, 2006
Last Update Posted : January 5, 2006
National Cancer Institute (NCI)
Information provided by:
Dartmouth-Hitchcock Medical Center

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.

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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

Primary Outcome Measures :
  1. colorectal adenomas during years 1-3 and years 4-8
  2. advanced colorectal adenomas during years 1-3 and years 4-8
  3. colorectal cancer

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

Inclusion Criteria:

  1. 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.
  2. An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
  3. Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
  4. Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
  5. Age between 21 and 80 years at the time of the intake colonoscopy.
  6. For women of childbearing potential, agreement to use effective birth control for the duration of the study.
  7. Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
  8. 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:

  1. Invasive carcinoma in any colonic polyp removed.
  2. Familial colonic polyposis syndromes.
  3. Ulcerative colitis or Crohn's disease.
  4. Malabsorption syndrome (e.g. pancreatic insufficiency).
  5. Large bowel resection for any reason.
  6. Diagnosed narcotic or alcohol dependence
  7. Contraindication to aspirin use, including:

    1. documented peptic ulcer disease in the past 20 years
    2. aspirin sensitivity
    3. bleeding diathesis, including hemorrhagic stroke
  8. 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
  9. Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
  10. Pregnancy or lactation.

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 identifier (NCT number): NCT00272324

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United States, California
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)
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Principal Investigator: John A Baron, MD, MSc Dartmouth-Hitchcock Medical Center

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00272324     History of Changes
Other Study ID Numbers: 5R01CA059005-12 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2006    Key Record Dates
Last Update Posted: January 5, 2006
Last Verified: November 2005
Keywords provided by Dartmouth-Hitchcock Medical Center:
Colorectal neoplasms
Adenomatous polyps
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Folic Acid
Vitamin B Complex
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Growth Substances