Clinical trial · Interventional
Selenium for Prevention of Adenomatous Colorectal Polyps
Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Concluded - Terminated by PI
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps. PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Colorectal Polyps | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selenium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Selenium
- description
- Participants receive oral selenium 200 mcg once daily.
- interventionNames
- Drug: Selenium
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants receive oral placebo once daily.
- interventionNames
- Drug: Selenium
Primary outcomes (2)
- measure
- Number of Recurrent Adenomas at Surveillance Colonoscopy
- timeFrame
- 3 to 5 years after baseline colonoscopy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal adenomatous polyps
* Meets the following criteria by colonoscopy (performed within the past 6 months):
* Cecum was totally visualized or reached
* At least 90% visualization of colon surface area
* Removed at least 1 adenomatous polyp of at least 3 mm in size during procedure (For the Advanced Adenoma Sub-study: Removal of at least 1 advanced colorectal adenomatous polyp during procedure. An adenoma is considered advanced if it is 10 mm or greater in size, and/or has villous histology and/or shows high grade dysplasia)
* Removed no more than 10 adenomatous polyps of any size by endoscopy
* All other neoplastic and non-neoplastic colon polyps must have been completely removed (except for diminutive \[less than 3 mm\] sessile rectal polyps)
* For the sub-study, at least 1 advanced adenomatous polyp defined as 10 mm or greater in size and/or has villous histology and/or shows high grade dysplasia
* No prior diagnosis of any of the following:
* Colorectal cancer
* Familial adenomatous polyposis
* Ulcerative colitis
* Crohn's disease
* Hereditary non-polyposis colon cancer (HNPCC), defined as:
* Histologically confirmed colorectal cancer in at least 3 relatives, 1 of whom is a first-degree relative of the other 2
* Disease occurrence in at least 2 consecutive generations
* Colorectal cancer diagnosis in at least 1 family member who is less than 50 years of age
* Patients with a family history of colorectal cancer but who are not diagnosed with HNPCC are allowed
* No more than 1 prior segmental colon resection
PATIENT CHARACTERISTICS:
Age
* 40 to 80
Performance status
* SWOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin \> 11 g/dL
* WBC 3,000 - 11,000/mm\^3
Hepatic
* AST and ALT \< 2 times upper limit of normal
* Bilirubin \< 2.0 mg/dL
Renal
* Creatinine \< 1.9 mg/dL
Cardiovascular
* No unstable\* cardiac disease despite medication (e.g., diuretics or digitalis)
* No uncontrolled hypertension (i.e., systolic blood pressure ≥ 170 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg) despite medication NOTE: \*Unstable defined as unable to walk across the room without chest pain or shortness of breath
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception for at least 2 months before and during study treatment
* Resident of a clinical center metropolitan area or obtaining regular health care in a clinical metropolitan area for at least 6 months out of the year
* Must be able to swallow pills
* No unexpected weight loss of 10% or more within the past 6 months
* No prior rheumatoid arthritis
* No poorly controlled diabetes mellitus despite medication, defined as:
* Blood sugar level ≥ 200 mg/dL on more than half of the readings taken within the past month
* No invasive malignancy within the past 5 years that required medical excision, radiotherapy, or chemotherapy except basal cell or squamous cell carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent drugs that regulate the immune system
Chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
Other
* Prior enrollment in another adenoma prevention study allowed
* Concurrent routine aspirin (≤ 81 mg/day) allowed
* No regular use of non-steroidal anti-inflammatory drugs (NSAIDs)
* No concurrent enrollment in another research study using pharmacological cancer drugs, a cyclo-oxygenase-2 inhibitor, or selenium
* No other concurrent selenium unless dosage is ≤ 50 µg/dayReferences
Publications (4)
- DERIVEDTrejo MJ, Batai K, Chen Y, Brezina S, Chow HS, Ellis N, Lance P, Hsu CH, Pogreba-Brown K, Bishop M, Gsur A, Jacobs ET. Genome-Wide Association Study of Metachronous Colorectal Adenoma Risk among Participants in the Selenium Trial. Nutr Cancer. 2023;75(1):143-153. doi: 10.1080/01635581.2022.2096910. Epub 2022 Jul 9. PMID 35815403
- DERIVEDJacobs ET, Lance P, Mandarino LJ, Ellis NA, Chow HS, Foote J, Martinez JA, Hsu CP, Batai K, Saboda K, Thompson PA. Selenium supplementation and insulin resistance in a randomized, clinical trial. BMJ Open Diabetes Res Care. 2019 Feb 7;7(1):e000613. doi: 10.1136/bmjdrc-2018-000613. eCollection 2019. PMID 30899530
- DERIVEDThompson P, Roe DJ, Fales L, Buckmeier J, Wang F, Hamilton SR, Bhattacharyya A, Green S, Hsu CH, Chow HH, Ahnen DJ, Boland CR, Heigh RI, Fay DE, Martinez ME, Jacobs E, Ashbeck EL, Alberts DS, Lance P. Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention. Cancer Prev Res (Phila). 2012 Dec;5(12):1381-93. doi: 10.1158/1940-6207.CAPR-12-0204. Epub 2012 Oct 11. PMID 23060037
- DERIVEDSolomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31. PMID 18378608