Aspirin/Folate Prevention of Large Bowel Polyps

Colorectal Cancer Clinical Trial

Official title:

Aspirin/Folate Prevention of Large Bowel Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272324
• Other study ID #: 5R01CA059005-12
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 1992
• Est. completion date: January 2007

Study information

• Verified date: March 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1121
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adenomas
• Colorectal Cancer
• Polyps

Intervention

Drug:
• Aspirin

• Folate

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Colorado	Denver	Colorado
United States	Henry Ford Health Sciences Center	Detroit	Michigan
United States	University of Iowa	Iowa City	Iowa
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	USC/Kaiser	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Baron JA, Cole BF, Sandler RS, Haile RW, Ahnen D, Bresalier R, McKeown-Eyssen G, Summers RW, Rothstein R, Burke CA, Snover DC, Church TR, Allen JI, Beach M, Beck GJ, Bond JH, Byers T, Greenberg ER, Mandel JS, Marcon N, Mott LA, Pearson L, Saibil F, van St — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 or more adenomas	colorectal adenomas detected at follow-up colonoscopy	For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
Secondary	number of adenomas	colorectal adenomas detected at follow-up colonoscopy	For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
Secondary	1 or more advanced lesions	adenomas measuring at least 1 cm in diameter or with tubulovillous or villous features, severe dysplasia, or invasive cancer	For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8