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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2015

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.

Interventions

  • Drug: Vitamin E
    • 400 IU daily by mouth for 7 – 12 years
  • Drug: Selenium
    • 200 mcg daily for 7 – 12 years
  • Drug: Vitamin E placebo
    • 1 pill by mouth daily for 7 – 12 years
  • Drug: selenium placebo
    • 1 pill by mouth daily for 7 – 12 years

Arms, Groups and Cohorts

  • Experimental: Vitamin E + selenium placebo
    • Vitamin E and selenium placebo daily for 7 – 12 years
  • Experimental: Selenium + vitamin E placebo
    • Selenium and vitamin E placebo daily for 7 – 12 years
  • Experimental: Vitamin E + selenium
    • Vitamin E and selenium daily for 7 – 12 years
  • Placebo Comparator: Vitamin E placebo + selenium placebo
    • Vitamin E placebo and selenium placebo daily for 7 – 12 years

Clinical Trial Outcome Measures

Primary Measures

  • 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 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 Occurrences of Multiple (>2) Adenomas
    • Time Frame: From 1 year post randomization through study completion

Secondary Measures

  • Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo
    • Time Frame: From 1 year post randomization through study completion

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 50 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Southwest Oncology Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • M. Peter Lance, MD, Principal Investigator, University of Arizona

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