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

S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00706121

Acronym

ACP

Enrollment

8094

Registered

2008-06-27

Start date

2008-06-30

Completion date

2018-01-31

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Precancerous Condition

Keywords

colon cancer, rectal cancer, adenomatous polyp

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.

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.

Interventions

DRUGVitamin E

400 IU daily by mouth for 7 - 12 years

DRUGSelenium

200 mcg daily for 7 - 12 years

DRUGVitamin E placebo

1 pill by mouth daily for 7 - 12 years

DRUGselenium placebo

1 pill by mouth daily for 7 - 12 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to 120 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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 Occurrences of Multiple (>2) Adenomas	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 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

Secondary

Measure	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

Other

Measure	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 Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo	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 Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo	From 1 year post randomization through study completion

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	1,643
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	1,700
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	1,626
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	1,577
Total	6,546

Baseline characteristics

Characteristic	Vitamin E + Selenium Placebo	Selenium + Vitamin E Placebo	Vitamin E + Selenium	Vitamin E Placebo + Selenium Placebo	Total
Age, Continuous	61.0 years	62.0 years	62.0 years	62.0 years	62.0 years
Age, Customized Age, Categorical 50-54	60 Participants	59 Participants	49 Participants	52 Participants	220 Participants
Age, Customized Age, Categorical 55-64	1025 Participants	1045 Participants	1002 Participants	933 Participants	4005 Participants
Age, Customized Age, Categorical 65-74	494 Participants	538 Participants	516 Participants	524 Participants	2072 Participants
Age, Customized Age, Categorical >= 75	64 Participants	58 Participants	59 Participants	68 Participants	249 Participants
BMI, Categorical Normal or underweight (<=25)	293 Participants	355 Participants	327 Participants	324 Participants	1299 Participants
BMI, Categorical Obese (>30)	528 Participants	545 Participants	492 Participants	484 Participants	2049 Participants
BMI, Categorical Overweight (>25 to 30)	818 Participants	795 Participants	800 Participants	764 Participants	3177 Participants
BMI, Continuous	27.8 kg/m^2	28.0 kg/m^2	27.8 kg/m^2	28.0 kg/m^2	27.9 kg/m^2
Education >=College graduate	944 Participants	980 Participants	992 Participants	931 Participants	3847 Participants
Education <=High school/GED	263 Participants	264 Participants	226 Participants	263 Participants	1016 Participants
Education Some college/vocational	432 Participants	447 Participants	397 Participants	378 Participants	1654 Participants
History of Cancer	38 Participants	32 Participants	35 Participants	30 Participants	135 Participants
History of Colon Polyps	355 Participants	347 Participants	339 Participants	355 Participants	1396 Participants
History of Colorectal Cancer	7 Participants	7 Participants	7 Participants	5 Participants	26 Participants
History of Diabetes	138 Participants	126 Participants	126 Participants	148 Participants	538 Participants
History of Diverticulitis	128 Participants	103 Participants	121 Participants	110 Participants	462 Participants
Medication Use -- Aspirin	756 Participants	769 Participants	775 Participants	736 Participants	3036 Participants
Medication Use -- Cox II Inhibitors	91 Participants	85 Participants	92 Participants	77 Participants	345 Participants
Medication Use -- Other NSAIDs	173 Participants	175 Participants	164 Participants	168 Participants	680 Participants
Medication Use -- Statins	280 Participants	297 Participants	283 Participants	284 Participants	1144 Participants
Number of First Degree Relatives with Colorectal Cancer 0	1347 Participants	1393 Participants	1350 Participants	1279 Participants	5369 Participants
Number of First Degree Relatives with Colorectal Cancer 1	185 Participants	198 Participants	181 Participants	196 Participants	760 Participants
Number of First Degree Relatives with Colorectal Cancer 2 or more	28 Participants	26 Participants	23 Participants	26 Participants	103 Participants
Race/Ethnicity, Customized Race/ethnicity Aboriginal	2 Participants	8 Participants	1 Participants	7 Participants	18 Participants
Race/Ethnicity, Customized Race/ethnicity African American	181 Participants	187 Participants	167 Participants	160 Participants	695 Participants
Race/Ethnicity, Customized Race/ethnicity Asian/Pacific Islander	12 Participants	22 Participants	11 Participants	9 Participants	54 Participants
Race/Ethnicity, Customized Race/ethnicity Hispanic, African American	2 Participants	1 Participants	1 Participants	0 Participants	4 Participants
Race/Ethnicity, Customized Race/ethnicity Hispanic, not African American	30 Participants	30 Participants	32 Participants	25 Participants	117 Participants
Race/Ethnicity, Customized Race/ethnicity Other	5 Participants	7 Participants	2 Participants	2 Participants	16 Participants
Race/Ethnicity, Customized Race/ethnicity White	1411 Participants	1445 Participants	1412 Participants	1374 Participants	5642 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	1643 Participants	1700 Participants	1626 Participants	1577 Participants	6546 Participants
Smoking Status Current	87 Participants	98 Participants	99 Participants	97 Participants	381 Participants
Smoking Status Former	826 Participants	815 Participants	800 Participants	767 Participants	3208 Participants
Smoking Status Never	729 Participants	785 Participants	726 Participants	711 Participants	2951 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	116 / 1,643	85 / 1,700	112 / 1,626	100 / 1,577
serious Total, serious adverse events	10 / 1,643	12 / 1,700	14 / 1,626	19 / 1,577