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.
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.
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
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- M. Peter Lance, MD, Principal investigator, University of Arizona
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
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.
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.
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
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.