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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

January 3, 2006
January 3, 2006
February 1992
Not Provided
  • colorectal adenomas during years 1-3 and years 4-8
  • advanced colorectal adenomas during years 1-3 and years 4-8
  • colorectal cancer
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Aspirin/Folate Prevention of Large Bowel Polyps
Aspirin/Folate Prevention of Large Bowel Polyps

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Colorectal Cancer
  • Polyps
  • Adenomas
  • Drug: Aspirin
  • Drug: Folate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1121
January 2007
Not Provided

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.
Both
21 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00272324
5 R01 CA 059005-12
Not Provided
Not Provided
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Principal Investigator: John A Baron, MD, MSc Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP