CompletedPhase 2/3

Aspirin/Folate Prevention of Large Bowel Polyps

United States1,121 participantsStarted 1992-02

Plain-language 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.

Who can participate

Age range21 Years – 80 Years

SexALL

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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:
✕. documented peptic ulcer disease in the past 20 years

What they're measuring

1 or more adenomas

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

Trial details

NCT IDNCT00272324

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

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