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Aspirin/Folate Prevention of Large Bowel Polyps

Phase 2/Phase 3
21 Years
80 Years
Not Enrolling
Colorectal Cancer, Polyps, Adenomas

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Trial Information

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 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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

colorectal adenomas during years 1-3 and years 4-8

Principal Investigator

John A Baron, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Food and Drug Administration

Study ID:

5 R01 CA 059005-12



Start Date:

February 1992

Completion Date:

January 2007

Related Keywords:

  • Colorectal Cancer
  • Polyps
  • Adenomas
  • Colorectal neoplasms
  • Adenomatous polyps
  • Adenoma
  • Colorectal Neoplasms
  • Polyps
  • Colonic Polyps



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University of ColoradoDenver, Colorado  80217
University of MinnesotaMinneapolis, Minnesota  55455
University of North CarolinaChapel Hill, North Carolina  27599
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
USC/KaiserLos Angeles, California  
Henry Ford Health Sciences CenterDetroit, Michigan