Polyp Prevention Trial

Completed · Phase 3

Conditions studied: Diet, Polyps, Adenoma

In brief

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 large bowel. Secondary objectives of the PPT include 1) evaluating the effectiveness of the intervention program with respect to participant achievement of dietary goals; 2) examining the relation of dietary change and biochemical markers in blood; and 3) assessing the impact of the intervention on quality of life indicators.

Key facts

Study ID

NCT00339625

Run by

National Cancer Institute (NCI)

People needed

2079

Starts

1991-06-19

Expected to finish

2020-05-11

Last updated by the study team

2020-05-15

Who can join

Age: 35 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• National Cancer Institute (NCI), 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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