S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 (ACP)
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| ClinicalTrials.gov Identifier: NCT00706121 |
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Recruitment Status :
Completed
First Posted : June 27, 2008
Results First Posted : April 4, 2017
Last Update Posted : December 16, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer Precancerous Condition | Drug: Vitamin E Drug: Selenium Drug: Vitamin E placebo Drug: selenium placebo | Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 8094 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 Start Date : | June 2008 |
| Actual Primary Completion Date : | October 2015 |
| Actual Study Completion Date : | January 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
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Drug: Vitamin E
400 IU daily by mouth for 7 - 12 years
Other Name: alpha tocopherol Drug: selenium placebo 1 pill by mouth daily for 7 - 12 years
Other Name: placebo |
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Experimental: Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
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Drug: Selenium
200 mcg daily for 7 - 12 years
Other Name: L-selenomethionine Drug: Vitamin E placebo 1 pill by mouth daily for 7 - 12 years
Other Name: placebo |
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Experimental: Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
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Drug: Vitamin E
400 IU daily by mouth for 7 - 12 years
Other Name: alpha tocopherol Drug: Selenium 200 mcg daily for 7 - 12 years
Other Name: L-selenomethionine |
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Placebo Comparator: Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
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Drug: Vitamin E placebo
1 pill by mouth daily for 7 - 12 years
Other Name: placebo Drug: selenium placebo 1 pill by mouth daily for 7 - 12 years
Other Name: placebo |
- 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 ]
- 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 ]
- Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo [ Time Frame: From 1 year post randomization through study completion ]
- Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From 1 year post randomization through study completion ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706121
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 86724 | |
| Principal Investigator: | M. Peter Lance, MD | University of Arizona |
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00706121 |
| Other Study ID Numbers: |
CDR0000593329 S0000D ( Other Identifier: SWOG ) U10CA037429 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 27, 2008 Key Record Dates |
| Results First Posted: | April 4, 2017 |
| Last Update Posted: | December 16, 2019 |
| Last Verified: | December 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | http://swog.org/Visitors/Download/Policies/Policy43.pdf |
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colon cancer rectal cancer adenomatous polyp |
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Vitamin E Tocopherols Tocotrienols alpha-Tocopherol Precancerous Conditions Neoplasms Vitamins Selenium |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Trace Elements |