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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Southwest Oncology Group

ClinicalTrials.gov Identifier:

NCT00706121

First received: June 26, 2008

Last updated: May 23, 2017

Last verified: May 2017

History of Changes

Results First Received: February 15, 2017

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Care Provider, Investigator, Outcomes Assessor; Primary Purpose: Prevention
Conditions:	Colorectal Cancer Precancerous Condition
Interventions:	Drug: Vitamin E Drug: Selenium Drug: Vitamin E placebo Drug: selenium placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Vitamin E + Selenium Placebo	Selenium + Vitamin E Placebo	Vitamin E + Selenium	Vitamin E Placebo + Selenium Placebo
STARTED	2039	2096	2030	1929
COMPLETED	1643	1700	1626	1577
NOT COMPLETED	396	396	404	352

Baseline Characteristics

Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

Vitamin E + Selenium Placebo

Selenium + Vitamin E Placebo

Vitamin E + Selenium

Vitamin E Placebo + Selenium Placebo

Total

Overall Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

Age
[Units: Years]
Median (Inter-Quartile Range)

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

61.0
(58.0 to 66.0)

62.0
(58.0 to 66.0)

62.0
(58.0 to 67.0)

62.0
(58.0 to 66.0)

Age, Customized
[Units: Participants]
Count of Participants

Age, Categorical

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

50-54

60 3.7%

59 3.5%

49 3.0%

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
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

Female

0 0.0%

Male

1643 100.0%

1700 100.0%

1626 100.0%

1577 100.0%

6546 100.0%

Race/Ethnicity, Customized
[Units: Participants]
Count of Participants

Race/ethnicity

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

White

1411 85.9%

1445 85.0%

1412 86.8%

1374 87.1%

5642 86.2%

African American

181 11.0%

187 11.0%

167 10.3%

160 10.1%

695 10.6%

Hispanic, not African American

30 1.8%

32 2.0%

25 1.6%

117 1.8%

Hispanic, African American

2 0.1%

1 0.1%

0 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%

16 0.2%

Education ^[1]
[Units: Participants]
Count of Participants

<=High school/GED

Participants Analyzed
[Units: Participants]

1639

1691

1615

1572

6517

<=High school/GED

263

264

226

263

1016

Some college/vocational

Participants Analyzed
[Units: Participants]

1639

1691

1615

1572

6517

Some college/vocational

432

447

397

378

1654

>=College graduate

Participants Analyzed
[Units: Participants]

1639

1691

1615

1572

6517

>=College graduate

944

980

992

931

3847

^[1]	Subjects missing education information excluded.

Smoking Status ^[1]
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1642

1698

1625

1575

6540

Never

729 44.4%

785 46.2%

726 44.7%

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 48.0%

800 49.2%

767 48.7%

3208 49.1%

^[1]	Subjects missing smoking history excluded.

BMI, Categorical ^[1]
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1639

1695

1619

1572

6525

Normal or underweight (<=25)

293 17.9%

355 20.9%

327 20.2%

324 20.6%

1299 19.9%

Overweight (>25 to 30)

818 49.9%

795 46.9%

800 49.4%

764 48.6%

3177 48.7%

Obese (>30)

528 32.2%

545 32.2%

492 30.4%

484 30.8%

2049 31.4%

^[1]	Subjects missing BMI excluded.

BMI, Continuous ^[1]
[Units: Kg/m^2]
Median (Inter-Quartile Range)

Participants Analyzed
[Units: Participants]

1639

1695

1619

1572

6525

27.8
(25.7 to 31.2)

28.0
(25.4 to 30.9)

27.8
(25.6 to 30.9)

28.0
(25.4 to 30.8)

27.9
(25.7 to 30.9)

^[1]	Subjects missing BMI excluded.

History of Cancer
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

135

History of Colorectal Cancer
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

History of Colon Polyps
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

355

347

339

355

1396

History of Diverticulitis
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

128

103

121

110

462

History of Diabetes
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

138

126

148

538

Number of First Degree Relatives with Colorectal Cancer ^[1]
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1560

1617

1554

1501

6232

1347 86.3%

1393 86.1%

1350 86.9%

1279 85.2%

5369 86.2%

185 11.9%

198 12.2%

181 11.6%

196 13.1%

760 12.2%

2 or more

28 1.8%

26 1.6%

23 1.5%

26 1.7%

103 1.7%

^[1]	Subjects missing FDR information excluded.

Medication Use -- Aspirin
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1643

1700

1626

1577

6546

756

769

775

736

3036

Medication Use -- Cox II Inhibitors ^[1]
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1641

1697

1624

1575

6537

345

^[1]	Subjects missing information on Cox II inhibitor use excluded.

Medication Use -- Other NSAIDs ^[1]
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

1641

1698

1626

1576

6541

173

175

164

168

680

^[1]	Subjects missing information on NSAID use excluded.

Medication Use -- Statins ^[1]
[Units: Participants]
Count of Participants

Participants Analyzed
[Units: Participants]

992

1050

1005

955

4002

280

297

283

284

1144

^[1]	Subjects missing information on or not asked about statin use excluded.

Outcome Measures

Show All Outcome Measures

1. Primary:

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 ]

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

3. Primary:

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

Show Outcome Measure 3

4. Primary:

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

Show Outcome Measure 4

5. Secondary:

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 ]

Show Outcome Measure 5

6. Other Pre-specified:

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 ]

Show Outcome Measure 6

7. Other Pre-specified:

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 ]

Show Outcome Measure 7

8. Other Pre-specified:

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 ]

Show Outcome Measure 8

9. Other Pre-specified:

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 ]

Show Outcome Measure 9

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

More Information

Hide More Information

Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: SELECT/S0000D Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00706121 History of Changes
Other Study ID Numbers:	CDR0000593329 S0000D ( Other Identifier: SWOG ) U10CA037429 ( U.S. NIH Grant/Contract )
Study First Received:	June 26, 2008
Results First Received:	February 15, 2017
Last Updated:	May 23, 2017

To Top