Clincosm LogoSign in Get a demo

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

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00706121
Collaborator
National Cancer Institute (NCI) (NIH)
8,094
Enrollment
1
Location
4
Arms
115
Duration (Months)
70.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin E
  • Drug: Selenium
  • Drug: Vitamin E placebo
  • Drug: selenium placebo
 Phase 3

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.

Study Design

Study Type:
Interventional
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 :
Jun 1, 2008
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin E + selenium placebo

Vitamin E and selenium placebo daily for 7 - 12 years

Drug: Vitamin E
400 IU daily by mouth for 7 - 12 years
Other Names:
  • alpha tocopherol

    • Drug: selenium placebo
    1 pill by mouth daily for 7 - 12 years
    Other Names:
  • placebo

    		•
    Experimental: Selenium + vitamin E placebo

    Selenium and vitamin E placebo daily for 7 - 12 years

    Drug: Selenium
    200 mcg daily for 7 - 12 years
    Other Names:
  • L-selenomethionine

    • Drug: Vitamin E placebo
    1 pill by mouth daily for 7 - 12 years
    Other Names:
  • placebo

    		•
    Experimental: Vitamin E + selenium

    Vitamin E and selenium daily for 7 - 12 years

    Drug: Vitamin E
    400 IU daily by mouth for 7 - 12 years
    Other Names:
  • alpha tocopherol

    • Drug: Selenium
    200 mcg daily for 7 - 12 years
    Other Names:
  • L-selenomethionine

    		•
    Placebo Comparator: Vitamin E placebo + selenium placebo

    Vitamin E placebo and selenium placebo daily for 7 - 12 years

    Drug: Vitamin E placebo
    1 pill by mouth daily for 7 - 12 years
    Other Names:
  • placebo

    • Drug: selenium placebo
    1 pill by mouth daily for 7 - 12 years
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo [From 1 year post randomization through study completion]

    2. Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo [From 1 year post randomization through study completion]

      Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia

    3. Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence [From 1 year post randomization through study completion]

    4. Effect of Selenium on Occurrences of Multiple (>2) Adenomas [From 1 year post randomization through study completion]

    Secondary Outcome Measures

    1. Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo [From 1 year post randomization through study completion]

    Other Outcome Measures

    1. 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]

    2. Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo [From 1 year post randomization through study completion]

    3. 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]

    4. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 120 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 86724

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: M. Peter Lance, MD, University of Arizona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00706121
    Other Study ID Numbers:
    • CDR0000593329
    • S0000D
    • U10CA037429
    First Posted:
    Jun 27, 2008
    Last Update Posted:
    Dec 16, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Southwest Oncology Group
    colon cancer
    rectal cancer
    adenomatous polyp
    Additional relevant MeSH terms:
    Precancerous Conditions
    Vitamins
    Vitamin E
    Tocopherols
    Tocotrienols
    alpha-Tocopherol
    Selenium

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Vitamin E + Selenium Placebo Selenium + Vitamin E Placebo Vitamin E + Selenium Vitamin E Placebo + Selenium Placebo
    Arm/Group Description 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 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 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 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
    Period Title: Overall Study
    STARTED 2039 2096 2030 1929
    COMPLETED 1643 1700 1626 1577
    NOT COMPLETED 396 396 404 352

    Baseline Characteristics

    Arm/Group Title Vitamin E + Selenium Placebo Selenium + Vitamin E Placebo Vitamin E + Selenium Vitamin E Placebo + Selenium Placebo Total
    Arm/Group Description 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 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 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 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 Total of all reporting groups
    Overall Participants 1643 1700 1626 1577 6546
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    61.0
    62.0
    62.0
    62.0
    62.0
    Age, Customized (Count of Participants)
    50-54
    60
    3.7%
    59
    3.5%
    49
    3%
    52
    3.3%
    220
    3.4%
    55-64
    1025
    62.4%
    1045
    61.5%
    1002
    61.6%
    933
    59.2%
    4005
    61.2%
    65-74
    494
    30.1%
    538
    31.6%
    516
    31.7%
    524
    33.2%
    2072
    31.7%
    >= 75
    64
    3.9%
    58
    3.4%
    59
    3.6%
    68
    4.3%
    249
    3.8%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    1643
    100%
    1700
    100%
    1626
    100%
    1577
    100%
    6546
    100%
    Race/Ethnicity, Customized (Count of Participants)
    White
    1411
    85.9%
    1445
    85%
    1412
    86.8%
    1374
    87.1%
    5642
    86.2%
    African American
    181
    11%
    187
    11%
    167
    10.3%
    160
    10.1%
    695
    10.6%
    Hispanic, not African American
    30
    1.8%
    30
    1.8%
    32
    2%
    25
    1.6%
    117
    1.8%
    Hispanic, African American
    2
    0.1%
    1
    0.1%
    1
    0.1%
    0
    0%
    4
    0.1%
    Aboriginal
    2
    0.1%
    8
    0.5%
    1
    0.1%
    7
    0.4%
    18
    0.3%
    Asian/Pacific Islander
    12
    0.7%
    22
    1.3%
    11
    0.7%
    9
    0.6%
    54
    0.8%
    Other
    5
    0.3%
    7
    0.4%
    2
    0.1%
    2
    0.1%
    16
    0.2%
    Education (Count of Participants)
    <=High school/GED
    263
    16%
    264
    15.5%
    226
    13.9%
    263
    16.7%
    1016
    15.5%
    Some college/vocational
    432
    26.3%
    447
    26.3%
    397
    24.4%
    378
    24%
    1654
    25.3%
    >=College graduate
    944
    57.5%
    980
    57.6%
    992
    61%
    931
    59%
    3847
    58.8%
    Smoking Status (Count of Participants)
    Never
    729
    44.4%
    785
    46.2%
    726
    44.6%
    711
    45.1%
    2951
    45.1%
    Current
    87
    5.3%
    98
    5.8%
    99
    6.1%
    97
    6.2%
    381
    5.8%
    Former
    826
    50.3%
    815
    47.9%
    800
    49.2%
    767
    48.6%
    3208
    49%
    BMI, Categorical (Count of Participants)
    Normal or underweight (<=25)
    293
    17.8%
    355
    20.9%
    327
    20.1%
    324
    20.5%
    1299
    19.8%
    Overweight (>25 to 30)
    818
    49.8%
    795
    46.8%
    800
    49.2%
    764
    48.4%
    3177
    48.5%
    Obese (>30)
    528
    32.1%
    545
    32.1%
    492
    30.3%
    484
    30.7%
    2049
    31.3%
    BMI, Continuous (kg/m^2) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [kg/m^2]
    27.8
    28.0
    27.8
    28.0
    27.9
    History of Cancer (Count of Participants)
    Count of Participants [Participants]
    38
    2.3%
    32
    1.9%
    35
    2.2%
    30
    1.9%
    135
    2.1%
    History of Colorectal Cancer (Count of Participants)
    Count of Participants [Participants]
    7
    0.4%
    7
    0.4%
    7
    0.4%
    5
    0.3%
    26
    0.4%
    History of Colon Polyps (Count of Participants)
    Count of Participants [Participants]
    355
    21.6%
    347
    20.4%
    339
    20.8%
    355
    22.5%
    1396
    21.3%
    History of Diverticulitis (Count of Participants)
    Count of Participants [Participants]
    128
    7.8%
    103
    6.1%
    121
    7.4%
    110
    7%
    462
    7.1%
    History of Diabetes (Count of Participants)
    Count of Participants [Participants]
    138
    8.4%
    126
    7.4%
    126
    7.7%
    148
    9.4%
    538
    8.2%
    Number of First Degree Relatives with Colorectal Cancer (Count of Participants)
    0
    1347
    82%
    1393
    81.9%
    1350
    83%
    1279
    81.1%
    5369
    82%
    1
    185
    11.3%
    198
    11.6%
    181
    11.1%
    196
    12.4%
    760
    11.6%
    2 or more
    28
    1.7%
    26
    1.5%
    23
    1.4%
    26
    1.6%
    103
    1.6%
    Medication Use -- Aspirin (Count of Participants)
    Count of Participants [Participants]
    756
    46%
    769
    45.2%
    775
    47.7%
    736
    46.7%
    3036
    46.4%
    Medication Use -- Cox II Inhibitors (Count of Participants)
    Count of Participants [Participants]
    91
    5.5%
    85
    5%
    92
    5.7%
    77
    4.9%
    345
    5.3%
    Medication Use -- Other NSAIDs (Count of Participants)
    Count of Participants [Participants]
    173
    10.5%
    175
    10.3%
    164
    10.1%
    168
    10.7%
    680
    10.4%
    Medication Use -- Statins (Count of Participants)
    Count of Participants [Participants]
    280
    17%
    297
    17.5%
    283
    17.4%
    284
    18%
    1144
    17.5%

    Outcome Measures

    1. Primary Outcome
    Title Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
    Description
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
    Arm/Group Title Active Selenium Selenium Placebo
    Arm/Group Description Active Selenium +/- Vitamin E Selenium Placebo +/- Vitamin E
    Measure Participants 3326 3220
    Count of Participants [Participants]
    1136
    69.1%
    1150
    67.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Active Selenium, Selenium Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.96
    Comments
    Method Log binomial regression
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    0.9 to 1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
    Description Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
    Arm/Group Title Active Selenium Selenium Placebo
    Arm/Group Description Active selenium +/- Vitamin E Selenium placebo +/- Vitamin E
    Measure Participants 3326 3220
    Count of Participants [Participants]
    269
    16.4%
    282
    16.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Active Selenium, Selenium Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.32
    Comments
    Method Log binomial regression
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.92
    Confidence Interval (2-Sided) 95%
    0.78 to 1.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    Title Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence
    Description
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Vitamin E Selenium Combination Placebo
    Arm/Group Description Vitamin E + matching placebo for selenium Selenium + matching placebo for vitamin E Vitamin E + selenium Matching placebo for vitamin E + matching placebo for selenium
    Measure Participants 1643 1700 1626 1577
    Count of Participants [Participants]
    10
    0.6%
    11
    0.6%
    9
    0.6%
    6
    0.4%
    4. Primary Outcome
    Title Effect of Selenium on Occurrences of Multiple (>2) Adenomas
    Description
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
    Arm/Group Title Active Selenium Selenium Placebo
    Arm/Group Description Active selenium +/- vitamin E Selenium placebo +/- vitamin E
    Measure Participants 3326 3220
    Count of Participants [Participants]
    258
    15.7%
    276
    16.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Active Selenium, Selenium Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.24
    Comments
    Method Log binomial regression
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 0.91
    Confidence Interval (2-Sided) 95%
    0.77 to 1.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo
    Description
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.
    Arm/Group Title Active Vitamin E Vitamin E Placebo
    Arm/Group Description Active vitamin E +/- selenium Vitamin E placebo +/- selenium
    Measure Participants 3269 3277
    Count of Participants [Participants]
    1159
    70.5%
    1127
    66.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Active Selenium, Selenium Placebo
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.38
    Comments
    Method Log binomial regression
    Comments
    Method of Estimation Estimation Parameter Risk Ratio (RR)
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    0.96 to 1.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Other Pre-specified Outcome
    Title Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
    Description
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
    Arm/Group Title Active Selenium Selenium Placebo
    Arm/Group Description Active selenium +/- vitamin E Selenium placebo +/- vitamin E
    Measure Participants 1133 1146
    Normal
    30.2
    1.8%
    31.4
    1.8%
    Overweight
    35.2
    2.1%
    36.5
    2.1%
    Obese
    35.2
    2.1%
    37.0
    2.2%
    7. Other Pre-specified Outcome
    Title Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
    Description
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
    Arm/Group Title Active Selenium Selenium Placebo
    Arm/Group Description Active selenium +/- vitamin E Selenium placebo +/- vitamin E
    Measure Participants 1136 1150
    Users
    33.5
    2%
    36.4
    2.1%
    Non-users
    34.9
    2.1%
    34.9
    2.1%
    8. Other Pre-specified Outcome
    Title Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
    Description
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.
    Arm/Group Title Active Vitamin E Vitamin E Placebo
    Arm/Group Description Active vitamin E +/- selenium Vitamin E placebo +/- selenium
    Measure Participants 1155 1124
    Normal
    30.2
    1.8%
    31.4
    1.8%
    Overweight
    36.8
    2.2%
    34.9
    2.1%
    Obese
    36.5
    2.2%
    35.7
    2.1%
    9. Other Pre-specified Outcome
    Title Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
    Description
    Time Frame From 1 year post randomization through study completion

    Outcome Measure Data

    Analysis Population Description
    Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.
    Arm/Group Title Active Vitamin E Vitamin E Placebo
    Arm/Group Description Active vitamin E +/- selenium Vitamin E placebo +/- selenium
    Measure Participants 1159 1127
    Users
    34.5
    2.1%
    35.3
    2.1%
    Non-users
    36.5
    2.2%
    33.3
    2%

    Adverse Events

    Time Frame Every 6 months while the participant is receiving study supplements.
    Adverse Event Reporting Description 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.
    Arm/Group Title Vitamin E + Selenium Placebo Selenium + Vitamin E Placebo Vitamin E + Selenium Vitamin E Placebo + Selenium Placebo
    Arm/Group Description 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 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 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 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
    All Cause Mortality
    Vitamin E + Selenium Placebo Selenium + Vitamin E Placebo Vitamin E + Selenium Vitamin E Placebo + Selenium Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Vitamin E + Selenium Placebo Selenium + Vitamin E Placebo Vitamin E + Selenium Vitamin E Placebo + Selenium Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/1643 (0.6%) 12/1700 (0.7%) 14/1626 (0.9%) 19/1577 (1.2%)
    Cardiac disorders
    Cardiac ischemia/infarction 2/1643 (0.1%) 5/1700 (0.3%) 7/1626 (0.4%) 6/1577 (0.4%)
    Cardiovascular-other 3/1643 (0.2%) 3/1700 (0.2%) 6/1626 (0.4%) 6/1577 (0.4%)
    Supraventricular arrhythmia 0/1643 (0%) 0/1700 (0%) 0/1626 (0%) 1/1577 (0.1%)
    Ventricular arrhythmia 1/1643 (0.1%) 0/1700 (0%) 0/1626 (0%) 0/1577 (0%)
    Injury, poisoning and procedural complications
    Surgery-hemorrhage 0/1643 (0%) 0/1700 (0%) 0/1626 (0%) 1/1577 (0.1%)
    Investigations
    Weight gain 0/1643 (0%) 0/1700 (0%) 0/1626 (0%) 1/1577 (0.1%)
    Nervous system disorders
    CNS hemorrhage 1/1643 (0.1%) 0/1700 (0%) 1/1626 (0.1%) 0/1577 (0%)
    Cerebrovascular ischemia 2/1643 (0.1%) 2/1700 (0.1%) 3/1626 (0.2%) 2/1577 (0.1%)
    Reproductive system and breast disorders
    Erectile impotence 0/1643 (0%) 1/1700 (0.1%) 0/1626 (0%) 0/1577 (0%)
    Respiratory, thoracic and mediastinal disorders
    Epistaxis 1/1643 (0.1%) 0/1700 (0%) 0/1626 (0%) 0/1577 (0%)
    Vascular disorders
    Carotid stenosis 1/1643 (0.1%) 0/1700 (0%) 0/1626 (0%) 0/1577 (0%)
    Peripheral arterial ischemia 0/1643 (0%) 0/1700 (0%) 0/1626 (0%) 1/1577 (0.1%)
    Thrombosis/embolism 0/1643 (0%) 1/1700 (0.1%) 0/1626 (0%) 1/1577 (0.1%)
    Other (Not Including Serious) Adverse Events
    Vitamin E + Selenium Placebo Selenium + Vitamin E Placebo Vitamin E + Selenium Vitamin E Placebo + Selenium Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 116/1643 (7.1%) 85/1700 (5%) 112/1626 (6.9%) 100/1577 (6.3%)
    Cardiac disorders
    Cardiac ischemia/infarction 116/1643 (7.1%) 85/1700 (5%) 112/1626 (6.9%) 100/1577 (6.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title SELECT/S0000D Statistician
    Organization SWOG Statistical Center
    Phone 206-667-4623
    Email
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00706121
    Other Study ID Numbers:
    • CDR0000593329
    • S0000D
    • U10CA037429
    First Posted:
    Jun 27, 2008
    Last Update Posted:
    Dec 16, 2019
    Last Verified:
    Dec 1, 2019