Aspirin/Folate Prevention of Large Bowel Polyps

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00272324
Collaborator
National Cancer Institute (NCI) (NIH)
1,121
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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
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

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Aspirin/Folate Prevention of Large Bowel Polyps
Study Start Date :
Feb 1, 1992
Study Completion Date :
Jan 1, 2007

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

  8. documented peptic ulcer disease in the past 20 years

  9. aspirin sensitivity

  10. bleeding diathesis, including hemorrhagic stroke

  11. Likelihood of NSAID use

  12. recurring arthritis or other musculo-skeletal problems

  13. frequent NSAID use in 5 years preceding

  14. history of stroke or TIAs

  15. history of angina or myocardial infarction

  16. desire to take aspirin for the prevention of cardiovascular disease

  17. Required or contraindicated folic acid use pernicious anemia or folic acid deficiency

  18. Pregnancy or lactation.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00272324
Other Study ID Numbers:
  • 5R01CA059005-12
First Posted:
Jan 5, 2006
Last Update Posted:
Mar 13, 2020
Last Verified:
Mar 1, 2020
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2020