Colorectal CancerPhase 3ACPNCT00706121

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

A Phase 3 study testing Vitamin E and Selenium in people with Colorectal Cancer and Precancerous Condition, run by SWOG Cancer Research Network at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 to 120 years, men onlyHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer, Precancerous Condition
What is being tested?: Vitamin E and Selenium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8,094 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Jan 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 120 years
Men only
Healthy volunteers accepted
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Arizona Cancer Center
Tucson, Arizona, 86724

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Colorectal Cancer, Precancerous Condition
Being tested: Vitamin E, Selenium, Vitamin E placebo, selenium placebo
Keywords: colon cancer, rectal cancer, adenomatous polyp
Medical subject headings: Colorectal Neoplasms, Precancerous Conditions, Colonic Neoplasms, Rectal Neoplasms, Adenomatous Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin EDrug
Also called alpha tocopherol
400 IU daily by mouth for 7 - 12 years
SeleniumDrug
Also called L-selenomethionine
200 mcg daily for 7 - 12 years
Vitamin E placeboDrug
Also called placebo
1 pill by mouth daily for 7 - 12 years
selenium placeboDrug
Also called placebo
1 pill by mouth daily for 7 - 12 years

Study groups in NCT00706121
Study group	Role	What they receive
Vitamin E + selenium placebo	Experimental	Vitamin E and selenium placebo daily for 7 - 12 years Receives: Drug: Vitamin E; Drug: selenium placebo
Selenium + vitamin E placebo	Experimental	Selenium and vitamin E placebo daily for 7 - 12 years Receives: Drug: Selenium; Drug: Vitamin E placebo
Vitamin E + selenium	Experimental	Vitamin E and selenium daily for 7 - 12 years Receives: Drug: Vitamin E; Drug: Selenium
Vitamin E placebo + selenium placebo	Placebo comparator	Vitamin E placebo and selenium placebo daily for 7 - 12 years Receives: Drug: Vitamin E placebo; Drug: selenium placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Measured: 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
Measured: From 1 year post randomization through study completion
Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence
Measured: From 1 year post randomization through study completion
Effect of Selenium on Occurrences of Multiple (>2) Adenomas
Measured: From 1 year post randomization through study completion

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jan 2018

First posted27 Jun 2008 (estimated)
Study startJun 2008
Primary completionOct 2015
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 8,094 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00706121
Sponsor's protocol ID: CDR0000593329
Other IDs: S0000D, U10CA037429
Acronym: ACP
Status last verified: Dec 2019
First submitted: 26 Jun 2008
Last updated: 16 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://swog.org/Visitors/Download/Policies/Policy43.pdf

Publications

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.
PubMed 27519183

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT
ClinicalTrials.gov ID: NCT00706121
Acronym / sponsor ID: ACP / CDR0000593329
Conditions: Colorectal Cancer, Precancerous Condition
Keywords: colon cancer, rectal cancer, adenomatous polyp
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 8,094 participants (actual)
Lead sponsor: SWOG Cancer Research NetworkResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Jun 2008
Primary completion: Oct 2015 (actual)
Study completion: Jan 2018 (actual)
First posted: 27 Jun 2008 (estimated)
Results: Posted 4 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Participants are followed annually.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Vitamin E + selenium placebo	Experimental	Drug: Vitamin E, Drug: selenium placeboVitamin E and selenium placebo daily for 7 - 12 years
Selenium + vitamin E placebo	Experimental	Drug: Selenium, Drug: Vitamin E placeboSelenium and vitamin E placebo daily for 7 - 12 years
Vitamin E + selenium	Experimental	Drug: Vitamin E, Drug: SeleniumVitamin E and selenium daily for 7 - 12 years
Vitamin E placebo + selenium placebo	Placebo comparator	Drug: Vitamin E placebo, Drug: selenium placeboVitamin E placebo and selenium placebo daily for 7 - 12 years

Who may qualify

Ages: 50 to 120 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin EAlso: alpha tocopherol400 IU daily by mouth for 7 - 12 years	Drug	Vitamin E + selenium, Vitamin E + selenium placebo
SeleniumAlso: L-selenomethionine200 mcg daily for 7 - 12 years	Drug	Selenium + vitamin E placebo, Vitamin E + selenium
Vitamin E placeboAlso: placebo1 pill by mouth daily for 7 - 12 years	Drug	Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo
selenium placeboAlso: placebo1 pill by mouth daily for 7 - 12 years	Drug	Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 4 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin E + Selenium Placebo	2,039	1,643
Selenium + Vitamin E Placebo	2,096	1,700
Vitamin E + Selenium	2,030	1,626
Vitamin E Placebo + Selenium Placebo	1,929	1,577

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Active Selenium n = 3326	Selenium Placebo n = 3220
Value	1136	1150

Active Selenium vs Selenium Placebo: Risk Ratio (RR): 0.96 (95% CI 0.9 to 1.02), p = 0.96, Log binomial regression

Population analysed: Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.

Primary outcome: Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo

Time frame: From 1 year post randomization through study completion. Count of participants. Unit: Participants

Measure	Active Selenium n = 3326	Selenium Placebo n = 3220
Value	269	282

Active Selenium vs Selenium Placebo: Risk Ratio (RR): 0.92 (95% CI 0.78 to 1.08), p = 0.32, Log binomial regression

Population analysed: Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.

Primary outcome: Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence

Time frame: From 1 year post randomization through study completion. Count of participants. Unit: Participants

Measure	Vitamin E n = 1643	Selenium n = 1700	Combination n = 1626	Placebo n = 1577
Value	10	11	9	6

Primary outcome: Effect of Selenium on Occurrences of Multiple (>2) Adenomas

Time frame: From 1 year post randomization through study completion. Count of participants. Unit: Participants

Measure	Active Selenium n = 3326	Selenium Placebo n = 3220
Value	258	276

Active Selenium vs Selenium Placebo: Risk Ratio (RR): 0.91 (95% CI 0.77 to 1.07), p = 0.24, Log binomial regression

Population analysed: Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Every 6 months while the participant is receiving study supplements.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin E + Selenium Placebo	10 of 1,643 (0.6%)	116 of 1,643 (7.1%)	Not reported
Selenium + Vitamin E Placebo	12 of 1,700 (0.7%)	85 of 1,700 (5%)	Not reported
Vitamin E + Selenium	14 of 1,626 (0.9%)	112 of 1,626 (6.9%)	Not reported
Vitamin E Placebo + Selenium Placebo	19 of 1,577 (1.2%)	100 of 1,577 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27519183Goodman 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.
Individual participant dataSharing planned: Yes. http://swog.org/Visitors/Download/Policies/Policy43.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

M. Peter Lance, MD principal investigator

University of Arizona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin E and Selenium in people with Colorectal Cancer and Precancerous Condition, run by SWOG Cancer Research Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00706121, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.