Aspirin/Folate Prevention of Large Bowel Polyps - Full Text View

Purpose

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	Intervention	Phase
Colorectal Cancer Polyps Adenomas	Drug: Aspirin Drug: Folate	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Aspirin/Folate Prevention of Large Bowel Polyps

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Colorectal Cancer Folic Acid

Drug Information available for: Aspirin Folic acid Vitamin B Complex

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

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


Estimated Enrollment:	1121
Study Start Date:	February 1992
Estimated Study Completion Date:	January 2007

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.

Eligibility


Ages Eligible for Study:	21 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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:
1. documented peptic ulcer disease in the past 20 years
2. aspirin sensitivity
3. bleeding diathesis, including hemorrhagic stroke
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
Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
Pregnancy or lactation.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272324

Locations


United States, California
USC/Kaiser
Los Angeles, California, United States
United States, Colorado
University of Colorado
Denver, Colorado, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, Michigan
Henry Ford Health Sciences Center
Detroit, Michigan, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Canada, Ontario
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

More Information

Publications:

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 Stolk RU. A randomized trial of aspirin to prevent colorectal adenomas. N Engl J Med. 2003 Mar 6;348(10):891-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hazra A, Selhub J, Chao WH, Ueland PM, Hunter DJ, Baron JA. Uracil misincorporation into DNA and folic acid supplementation. Am J Clin Nutr. 2010 Jan;91(1):160-5. doi: 10.3945/ajcn.2009.28527. Epub 2009 Nov 18.

Cole BF, Baron JA, Sandler RS, Haile RW, Ahnen DJ, Bresalier RS, McKeown-Eyssen G, Summers RW, Rothstein RI, Burke CA, Snover DC, Church TR, Allen JI, Robertson DJ, Beck GJ, Bond JH, Byers T, Mandel JS, Mott LA, Pearson LH, Barry EL, Rees JR, Marcon N, Saibil F, Ueland PM, Greenberg ER; Polyp Prevention Study Group. Folic acid for the prevention of colorectal adenomas: a randomized clinical trial. JAMA. 2007 Jun 6;297(21):2351-9.


ClinicalTrials.gov Identifier:	NCT00272324 History of Changes
Other Study ID Numbers:	5R01CA059005-12
Study First Received:	January 3, 2006
Last Updated:	January 3, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:


Colorectal neoplasms Adenomatous polyps

Additional relevant MeSH terms:


Colorectal Neoplasms Polyps Adenoma Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Pathological Conditions, Anatomical Neoplasms, Glandular and Epithelial	Neoplasms by Histologic Type Aspirin Folic Acid Vitamin B Complex Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016