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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer, Precancerous Condition

Intervention / Treatment
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* Drug: Vitamin E
* Drug: Selenium
* Drug: Vitamin E placebo
* Drug: selenium placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E + selenium placebo<br>Vitamin E and selenium placebo daily for 7 - 12 years | Drug: Vitamin E<br>* 400 IU daily by mouth for 7 - 12 years<br>* Other names: alpha tocopherol;Drug: selenium placebo<br>* 1 pill by mouth daily for 7 - 12 years<br>* Other names: placebo;|
| Experimental: Selenium + vitamin E placebo<br>Selenium and vitamin E placebo daily for 7 - 12 years | Drug: Selenium<br>* 200 mcg daily for 7 - 12 years<br>* Other names: L-selenomethionine;Drug: Vitamin E placebo<br>* 1 pill by mouth daily for 7 - 12 years<br>* Other names: placebo;|
| Experimental: Vitamin E + selenium<br>Vitamin E and selenium daily for 7 - 12 years | Drug: Vitamin E<br>* 400 IU daily by mouth for 7 - 12 years<br>* Other names: alpha tocopherol;Drug: Selenium<br>* 200 mcg daily for 7 - 12 years<br>* Other names: L-selenomethionine;|
| Placebo Comparator: Vitamin E placebo + selenium placebo<br>Vitamin E placebo and selenium placebo daily for 7 - 12 years | Drug: Vitamin E placebo<br>* 1 pill by mouth daily for 7 - 12 years<br>* Other names: placebo;Drug: selenium placebo<br>* 1 pill by mouth daily for 7 - 12 years<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo |  | From 1 year post randomization through study completion | 
| Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo | Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia | From 1 year post randomization through study completion | 
| Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence |  | From 1 year post randomization through study completion | 
| Effect of Selenium on Occurrences of Multiple (>2) Adenomas |  | From 1 year post randomization through study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo |  | From 1 year post randomization through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer, adenomatous polyp