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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
Drug: AspirinDrug: Folate
Phase 2Phase 3
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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Ages Eligible for Study:
21 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.