NCT00706121

S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000

S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,094 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Male
• Age: 50 Years – 120 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment. PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.

Detailed description

OBJECTIVES: Primary * To assess the effect of selenium on colorectal adenoma (CRA) occurrence. * To assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA. * To assess the effect of selenium on colorectal cancer (CRC) incidence. Secondary * To assess the effect of vitamin E on CRA occurrence. * To assess the effect of vitamin E on CRC incidence. Tertiary * To explore the effect modification of selenium and vitamin E by aspirin on CRA occurrence. * To explore the effect modification of selenium and vitamin E by body mass index. OUTLINE: This is a multicenter study. Endoscopically obtained tissue samples are reviewed by study pathologists to confirm the presence (or absence) of a colorectal adenoma (CRA). If a CRA is present, the number, location, size, histology, and degree of dysplasia are documented. The CRA is also reviewed to exclude a diagnosis of colorectal cancer. Additional data, including aspirin use, height and weight, date of birth, and other demographic and baseline characteristics, is also obtained. Participants' medical records are reviewed periodically. Participants are followed annually.

Conditions

• Colorectal Cancer
• Precancerous Condition

Interventions

Type	Name	Description
DRUG	Vitamin E	400 IU daily by mouth for 7 - 12 years
DRUG	Selenium	200 mcg daily for 7 - 12 years
DRUG	Vitamin E placebo	1 pill by mouth daily for 7 - 12 years
DRUG	selenium placebo	1 pill by mouth daily for 7 - 12 years

Timeline

• Start date: 2008-06-01
• Primary completion: 2015-10-01
• Completion: 2018-01-01
• First posted: 2008-06-27
• Last updated: 2019-12-16
• Results posted: 2017-04-04

Locations

1 site across 1 country: United States