Clinical trial · Interventional
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
NCT00706121CI-TRIAL-00042286ACPcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selenium | Drug | — | UNRESOLVED |
| selenium placebo | Drug | — | UNRESOLVED |
| Vitamin E | Drug | — | UNRESOLVED |
| Vitamin E placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Vitamin E + selenium placebo
- description
- Vitamin E and selenium placebo daily for 7 - 12 years
- interventionNames
- Drug: Vitamin E
- Drug: selenium placebo
- type
- EXPERIMENTAL
- label
- Selenium + vitamin E placebo
- description
- Selenium and vitamin E placebo daily for 7 - 12 years
- interventionNames
- Drug: Selenium
- Drug: Vitamin E placebo
- type
- EXPERIMENTAL
- label
- Vitamin E + selenium
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGoodman 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. PMID 27519183