Polyp Prevention Trial

NCT00339625 | Completed Phase 3

• 2 other identifiers: 9999910159OH91-C-0159
• Study Type: interventional
• Target: 2,079
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diet; Polyps; Adenoma

Keywords

Intervention; Diet; Colon

Outcome Measures

Primary Outcomes (1)

• Incidence of polyps in the colon

  Adenoma recurrence

  Yearly for 4 years

Study Arms (2)

1

EXPERIMENTAL

low fat, high fiber, high fruit and vegetable eating plan

Other: low fat, high fiber, high fruit and vegetable eating plan

2

NO INTERVENTION

Usual Diet

Interventions

low fat, high fiber, high fruit and vegetable eating plan OTHER

Participants were randomized to a low fat, high fiber, high fruit and vegetable (intervention arm) or their usual diet (control arm)

1

Eligibility Criteria

• Age: 35 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

• Hill MJ, Morson BC, Bussey HJ. Aetiology of adenoma--carcinoma sequence in large bowel. Lancet. 1978 Feb 4;1(8058):245-7. doi: 10.1016/s0140-6736(78)90487-7.

  PMID: 74668 BACKGROUND

• Zaridze DG. Environmental etiology of large-bowel cancer. J Natl Cancer Inst. 1983 Mar;70(3):389-400. No abstract available.

  PMID: 6300495 BACKGROUND

• Drasar BS, Irving D. Environmental factors and cancer of the colon and breast. Br J Cancer. 1973 Feb;27(2):167-72. doi: 10.1038/bjc.1973.20.

  PMID: 4694388 BACKGROUND

• Byrd DA, Vogtmann E, Ortega-Villa AM, Wan Y, Gomez M, Hogue S, Warner A, Zhu B, Dagnall C, Jones K, Hicks B, Albert PS, Murphy G, Sinha R. Prospective and Cross-sectional Associations of the Rectal Tissue Microbiome with Colorectal Adenoma Recurrence. Cancer Epidemiol Biomarkers Prev. 2023 Mar 6;32(3):435-443. doi: 10.1158/1055-9965.EPI-22-0608.

  PMID: 36525653 DERIVED

• Perera T, Young MR, Zhang Z, Murphy G, Colburn NH, Lanza E, Hartman TJ, Cross AJ, Bobe G. Identification and monitoring of metabolite markers of dry bean consumption in parallel human and mouse studies. Mol Nutr Food Res. 2015 Apr;59(4):795-806. doi: 10.1002/mnfr.201400847. Epub 2015 Feb 23.

  PMID: 25641932 DERIVED

MeSH Terms

Conditions

Polyps; Adenoma

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Gwen A Murphy

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 19, 1991
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-04

Locations

US (1)