Polyp Prevention Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00339625
First received: June 19, 2006
Last updated: April 8, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Polyp Prevention
Behavioral: Diet Assessment
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Polyp Prevention Trial

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 2440
Study Start Date: June 1991
Study Completion Date: April 2011
Intervention Details:
    Behavioral: Diet Assessment
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  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: NCT00339625

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Gwen A Murphy National Cancer Institute (NCI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00339625     History of Changes
Other Study ID Numbers: 9999910159, OH91-C-0159
Study First Received: June 19, 2006
Last Updated: April 8, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adenomatous Polyp
Dietary Intervention
Large Bowel

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014