S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT
Overview
- Phase
- Phase 3
- Intervention
- Vitamin E
- Conditions
- Colorectal Cancer
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 8094
- Locations
- 1
- Primary Endpoint
- Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
Intervention: Vitamin E
Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
Intervention: selenium placebo
Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
Intervention: Selenium
Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
Intervention: Vitamin E placebo
Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
Intervention: Vitamin E
Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
Intervention: Selenium
Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Intervention: Vitamin E placebo
Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Intervention: selenium placebo
Outcomes
Primary Outcomes
Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
Time Frame: From 1 year post randomization through study completion
Adenomas with diameter \>=1cm or any adenoma with villous features or high-grade dysplasia
Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence
Time Frame: From 1 year post randomization through study completion
Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Time Frame: From 1 year post randomization through study completion
Effect of Selenium on Occurrences of Multiple (>2) Adenomas
Time Frame: From 1 year post randomization through study completion
Secondary Outcomes
- Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo(From 1 year post randomization through study completion)