Clinical trial NCT00706121: S0000D: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Precancerous Condition
Keywords: colon cancer
rectal cancer
adenomatous polyp
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-06-27
Enrollment: 8094
Sex: MALE
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
timeFrame: From 1 year post randomization through study completion
measure: Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
timeFrame: From 1 year post randomization through study completion
measure: Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence
timeFrame: From 1 year post randomization through study completion
measure: Effect of Selenium on Occurrences of Multiple (>2) Adenomas
timeFrame: From 1 year post randomization through study completion
Secondary outcomes:
measure: Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo
timeFrame: From 1 year post randomization through study completion
Other outcomes:
measure: Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
timeFrame: From 1 year post randomization through study completion
measure: Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
timeFrame: From 1 year post randomization through study completion
measure: Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
timeFrame: From 1 year post randomization through study completion
measure: Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
timeFrame: From 1 year post randomization through study completion
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: M. Peter Lance, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.