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

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

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.

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.

Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo

Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo

Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo

DISEASE CHARACTERISTICS: Enrolled on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 Screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after randomization on SELECT trial PATIENT CHARACTERISTICS: Willing to sign an applicable medical records release form Willing to allow the release of tissue for central pathology review of resected polyps and endoscopic biopsies PRIOR CONCURRENT THERAPY: See Disease Characteristics

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.