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

Phase 3 Completed 8094 enrolled SWOG Cancer Research Network National Cancer Institute (NCI) · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2008-06
Primary completion: 2015-10
Completion: 2018-01

Outcome

Missed primary endpoint

registry analysis (unspecified test); Active Selenium vs Selenium Placebo; p = 0.96; Risk Ratio (RR) 0.96 (95% CI 0.9 to 1.02); Log binomial regression NCT00706121 ↗

registry analysis (unspecified test); Active Selenium vs Selenium Placebo; p = 0.32; Risk Ratio (RR) 0.92 (95% CI 0.78 to 1.08); Log binomial regression NCT00706121 ↗

registry analysis (unspecified test); Active Selenium vs Selenium Placebo; p = 0.24; Risk Ratio (RR) 0.91 (95% CI 0.77 to 1.07); Log binomial regression NCT00706121 ↗

Publications

Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selenium	Other / unclassified	200 ug	Oral
Subject	Vitamin E	Other / unclassified	400 iu	Oral