Status:
COMPLETED
Aspirin/Folate Prevention of Large Bowel Polyps
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Polyps
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
PHASE3
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.
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 hist...
Eligibility Criteria
Inclusion
- 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
- 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
- aspirin sensitivity
- bleeding diathesis, including hemorrhagic stroke
- Likelihood of NSAID use
- recurring arthritis or other musculo-skeletal problems
- frequent NSAID use in 5 years preceding
- history of stroke or TIAs
- history of angina or myocardial infarction
- desire to take aspirin for the prevention of cardiovascular disease
- Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
- Pregnancy or lactation.
Key Trial Info
Start Date :
February 1 1992
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
1121 Patients enrolled
Trial Details
Trial ID
NCT00272324
Start Date
February 1 1992
End Date
January 1 2007
Last Update
March 13 2020
Active Locations (9)
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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