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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Precancerous Condition
• Intervention / Treatment: Drug: Vitamin E; Drug: selenium placebo; Drug: Selenium; Drug: Vitamin E placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 8094
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 86724
      • Arizona Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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	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

Other Outcome Measures

Outcome Measure	Time Frame
Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo	From 1 year post randomization through study completion
Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo	From 1 year post randomization through study completion
Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo	From 1 year post randomization through study completion
Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo	From 1 year post randomization through study completion

Collaborators and Investigators

• Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: June 26, 2008
• First Submitted That Met QC Criteria: June 26, 2008
• First Posted (Estimate): June 27, 2008

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: rectal cancer; colon cancer; adenomatous polyp
• Additional Relevant MeSH Terms: Neoplasms; Precancerous Conditions; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Tocotrienols; Selenium
• Other Study ID Numbers: CDR0000593329; U10CA037429 (U.S. NIH Grant/Contract); S0000D (Other Identifier: SWOG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://swog.org/Visitors/Download/Policies/Policy43.pdf