S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000
NCT ID: NCT00706121
Last Updated: 2019-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
8094 participants
INTERVENTIONAL
2008-06-30
2018-01-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
Vitamin E
400 IU daily by mouth for 7 - 12 years
selenium placebo
1 pill by mouth daily for 7 - 12 years
Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
Selenium
200 mcg daily for 7 - 12 years
Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
Vitamin E
400 IU daily by mouth for 7 - 12 years
Selenium
200 mcg daily for 7 - 12 years
Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
selenium placebo
1 pill by mouth daily for 7 - 12 years
Interventions
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Vitamin E
400 IU daily by mouth for 7 - 12 years
Selenium
200 mcg daily for 7 - 12 years
Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
selenium placebo
1 pill by mouth daily for 7 - 12 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
120 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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M. Peter Lance, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Countries
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References
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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.
Other Identifiers
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S0000D
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000593329
Identifier Type: -
Identifier Source: org_study_id