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

Condition(s) targeted: Colorectal Cancer; Precancerous Condition

Intervention: Vitamin E (Drug); Selenium (Drug); Vitamin E placebo (Drug); selenium placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
M. Peter Lance, MD, Principal Investigator, Affiliation: University of Arizona

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Effect of selenium on colorectal adenoma (CRA) occurrence and colorectal cancer (CRC) incidence

Effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA

Secondary outcome:

Effect of vitamin E on CRA occurrence and CRC incidence

Effect modification of selenium and vitamin E by aspirin on CRA occurrence

Effect modification of selenium and vitamin E by body mass index

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.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Arizona Cancer Center, Tucson, Arizona 86724, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2008
Last updated: May 22, 2015