Aspirin/Folate Prevention of Large Bowel Polyps
Study Details
Study Description
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 |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 1 or more adenomas [For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8]
colorectal adenomas detected at follow-up colonoscopy
Secondary Outcome Measures
- number of adenomas [For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8]
colorectal adenomas detected at follow-up colonoscopy
- 1 or more advanced lesions [For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8]
adenomas measuring at least 1 cm in diameter or with tubulovillous or villous features, severe dysplasia, or invasive cancer
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
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Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
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Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
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Age between 21 and 80 years at the time of the intake colonoscopy.
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For women of childbearing potential, agreement to use effective birth control for the duration of the study.
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Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
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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:
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Invasive carcinoma in any colonic polyp removed.
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Familial colonic polyposis syndromes.
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Ulcerative colitis or Crohn's disease.
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Malabsorption syndrome (e.g. pancreatic insufficiency).
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Large bowel resection for any reason.
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Diagnosed narcotic or alcohol dependence
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Contraindication to aspirin use, including:
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documented peptic ulcer disease in the past 20 years
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aspirin sensitivity
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bleeding diathesis, including hemorrhagic stroke
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Likelihood of NSAID use
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recurring arthritis or other musculo-skeletal problems
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frequent NSAID use in 5 years preceding
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history of stroke or TIAs
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history of angina or myocardial infarction
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desire to take aspirin for the prevention of cardiovascular disease
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Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
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Pregnancy or lactation.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | USC/Kaiser | Los Angeles | California | United States | |
2 | University of Colorado | Denver | Colorado | United States | |
3 | University of Iowa | Iowa City | Iowa | United States | |
4 | Henry Ford Health Sciences Center | Detroit | Michigan | United States | |
5 | University of Minnesota | Minneapolis | Minnesota | United States | |
6 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03766 |
7 | University of North Carolina | Chapel Hill | North Carolina | United States | |
8 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | |
9 | University of Toronto | Toronto | Ontario | Canada |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: John A Baron, MD, MSc, Dartmouth-Hitchcock Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5R01CA059005-12