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| ID | Type | Description | Link |
|---|---|---|---|
| S0000D | Other Identifier | SWOG | |
| U10CA037429 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
Tertiary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin E + selenium placebo | Experimental | Vitamin E and selenium placebo daily for 7 - 12 years |
|
| Selenium + vitamin E placebo | Experimental | Selenium and vitamin E placebo daily for 7 - 12 years |
|
| Vitamin E + selenium | Experimental | Vitamin E and selenium daily for 7 - 12 years |
|
| Vitamin E placebo + selenium placebo | Placebo Comparator | Vitamin E placebo and selenium placebo daily for 7 - 12 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E | Drug | 400 IU daily by mouth for 7 - 12 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo | From 1 year post randomization through study completion | |
| Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo | Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia | From 1 year post randomization through study completion |
| Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence | From 1 year post randomization through study completion | |
| Effect of Selenium on Occurrences of Multiple (>2) Adenomas | From 1 year post randomization through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo | From 1 year post randomization through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo | From 1 year post randomization through study completion | |
| Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| M. Peter Lance, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 86724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27519183 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Selenium + Vitamin E Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo | Marginal analyses were performed, with arms pooled based on active vs. placebo selenium. | Posted | Count of Participants | Participants | From 1 year post randomization through study completion |
|
|
Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SELECT/S0000D Statistician | SWOG Statistical Center | 206-667-4623 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011230 | Precancerous Conditions |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D018256 | Adenomatous Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D024502 | alpha-Tocopherol |
| D012643 | Selenium |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Selenium | Drug | 200 mcg daily for 7 - 12 years |
|
|
| Vitamin E placebo | Drug | 1 pill by mouth daily for 7 - 12 years |
|
|
| selenium placebo | Drug | 1 pill by mouth daily for 7 - 12 years |
|
|
| 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 | 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 | From 1 year post randomization through study completion |
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
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Subjects missing education information excluded. | Count of Participants | Participants |
|
| Smoking Status | Subjects missing smoking history excluded. | Count of Participants | Participants |
|
| BMI, Categorical | Subjects missing BMI excluded. | Count of Participants | Participants |
|
| BMI, Continuous | Subjects missing BMI excluded. | Median | Inter-Quartile Range | kg/m^2 |
|
| History of Cancer | Count of Participants | Participants |
|
| History of Colorectal Cancer | Count of Participants | Participants |
|
| History of Colon Polyps | Count of Participants | Participants |
|
| History of Diverticulitis | Count of Participants | Participants |
|
| History of Diabetes | Count of Participants | Participants |
|
| Number of First Degree Relatives with Colorectal Cancer | Subjects missing FDR information excluded. | Count of Participants | Participants |
|
| Medication Use -- Aspirin | Count of Participants | Participants |
|
| Medication Use -- Cox II Inhibitors | Subjects missing information on Cox II inhibitor use excluded. | Count of Participants | Participants |
|
| Medication Use -- Other NSAIDs | Subjects missing information on NSAID use excluded. | Count of Participants | Participants |
|
| Medication Use -- Statins | Subjects missing information on or not asked about statin use excluded. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo | Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia | Marginal analyses were performed, with arms pooled based on active vs. placebo selenium. | Posted | Count of Participants | Participants | From 1 year post randomization through study completion |
|
|
|
|
| Primary | Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence | Posted | Count of Participants | Participants | From 1 year post randomization through study completion |
|
|
|
| Primary | Effect of Selenium on Occurrences of Multiple (>2) Adenomas | Marginal analyses were performed, with arms pooled based on active vs. placebo selenium. | Posted | Count of Participants | Participants | From 1 year post randomization through study completion |
|
|
|
|
| Secondary | Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo | Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E. | Posted | Count of Participants | Participants | From 1 year post randomization through study completion |
|
|
|
|
| Other Pre-specified | Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo | Marginal analyses were performed, with arms pooled based on active vs. placebo selenium. | Posted | Number | percentage of participants | From 1 year post randomization through study completion |
|
|
|
| Other Pre-specified | Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo | Marginal analyses were performed, with arms pooled based on active vs. placebo selenium. | Posted | Number | ercentage of participants in subgroup | From 1 year post randomization through study completion |
|
|
|
| Other Pre-specified | Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo | Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E. | Posted | Number | ercentage of participants in subgroup | From 1 year post randomization through study completion |
|
|
|
| Other Pre-specified | Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo | Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E. | Posted | Number | ercentage of participants in subgroup | From 1 year post randomization through study completion |
|
|
|
| 10 |
| 1,643 |
| 116 |
| 1,643 |
| EG001 | 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 | 12 | 1,700 | 85 | 1,700 |
| EG002 | 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 | 14 | 1,626 | 112 | 1,626 |
| EG003 | 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 | 19 | 1,577 | 100 | 1,577 |
| Cardiovascular-other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Supraventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Surgery-hemorrhage | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| CNS hemorrhage | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Cerebrovascular ischemia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Erectile impotence | Reproductive system and breast disorders | CTCAE (2.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Carotid stenosis | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Peripheral arterial ischemia | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024505 | Tocopherols |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| 55-64 |
|
| 65-74 |
|
| >= 75 |
|
| Male |
|
| African American |
|
| Hispanic, not African American |
|
| Hispanic, African American |
|
| Aboriginal |
|
| Asian/Pacific Islander |
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| Other |
|
|
|
| Current |
|
| Former |
|
| Overweight (>25 to 30) |
|
| Obese (>30) |
|
| 1 |
|
| 2 or more |
|
| Obese |
|
| Obese |
|