Status:
COMPLETED
Polyp Prevention Trial
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Diet
Polyps
Eligibility:
All Genders
35-99 years
Phase:
PHASE3
Brief Summary
The primary objective of the Poly Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the l...
Detailed Description
OBJECTIVES: The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous p...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Men and women who at the time of randomization are 35 years of age or older and have had removed within 6 months of randomization one or more adenomatous polyps confirmed histologically by the Clinical Center trial pathologist.
- EXCLUSION CRITERIA:
- Persons with any of the following characteristics are ineligible for the study:
- Carcinoma in any polyp removed at baseline endoscopy. High grade dysplasia is not considered carcinoma for purposes of study eligibility.
- Failure to examine the cecum during baseline colonoscopy.
- Incomplete removal of polyps at baseline colonoscopy.
- Surgical removal of polyps.
- Familial polyposis or other polyposis syndromes.
- Adenomatous polyp discovered before the age of 35.
- History of large bowel cancer, including intramucosal carcinoma.
- History of histologically or radiographically confirmed inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- History of large bowel resection.
- Weight move than 150% of desirable weight according to the 1983 Metropolitan Life Insurance Tables.
- Use of lipid-lowering drugs in pharmacologic doses in the last month.
- Major life-limiting conditions reducing likelihood of completing 4-year follow-up.
- Already consuming a dietary pattern similar to the intervention eating plan.
- Any dietary practice, behavior, or attitude that would substantially limit adherence to the intervention program.
- Participation in other clinical studies that may interfere with participation in the PPT.
- Unable or unwilling to sign informed consent form.
- Found to be unreliable and uncooperative providers of dietary information during the pre-randomization period.
- Able to give reasonable assurance of remaining in the Clinical Center area for duration of the study.
Exclusion
Key Trial Info
Start Date :
June 19 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2020
Estimated Enrollment :
2079 Patients enrolled
Trial Details
Trial ID
NCT00339625
Start Date
June 19 1991
End Date
May 11 2020
Last Update
May 15 2020
Active Locations (1)
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1
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892