Aspirin/Folate Prevention of Large Bowel Polyps

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00272324
First received: January 3, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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 Intervention Phase
Colorectal Cancer
Polyps
Adenomas
Drug: Aspirin
Drug: Folate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Aspirin/Folate Prevention of Large Bowel Polyps

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

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

Estimated Enrollment: 1121
Study Start Date: February 1992
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272324

Locations
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
Investigators
Principal Investigator: John A Baron, MD, MSc Dartmouth-Hitchcock Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00272324     History of Changes
Other Study ID Numbers: 5 R01 CA 059005-12
Study First Received: January 3, 2006
Last Updated: January 3, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:
Colorectal neoplasms
Adenomatous polyps

Additional relevant MeSH terms:
Colorectal Neoplasms
Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Aspirin
Vitamin B Complex
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents

ClinicalTrials.gov processed this record on September 18, 2014