NCT00078897 is a Phase 3 clinical trial of Selenium in Colorectal Cancer, sponsored by University of Arizona.

Who is sponsoring NCT00078897?

NCT00078897 is sponsored by University of Arizona.

What drugs are being tested in NCT00078897?

Interventions in NCT00078897: Selenium.

What condition does NCT00078897 study?

NCT00078897 studies Colorectal Cancer, Adenomatous Colorectal Polyps, Precancerous Condition.

Is NCT00078897 still recruiting?

NCT00078897 is currently terminated. Last updated 24 September 2019.

Are results published for NCT00078897?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-09-24 · How we verify

NCT00078897

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Selenium for Prevention of Adenomatous Colorectal Polyps

Terminated Phase 3 Results posted Last updated 24 September 2019

What this trial tests

Phase 3 trial testing Selenium in Colorectal Cancer in 1,621 participants. Terminated before completion.

Timeline

20 January 2005

Primary endpoint
7 January 2014

17 May 2018

Quick facts

Lead sponsor	University of Arizona
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,621
Start date	20 January 2005
Primary completion	7 January 2014
Estimated completion	17 May 2018
Sites	7 locations across United States

Drugs / interventions tested

Selenium (SELENIUM) — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Adenomatous Colorectal Polyps — all drugs for Adenomatous Colorectal Polyps →
Precancerous Condition — all drugs for Precancerous Condition →

Sponsor

University of Arizona

Who can join

Adults 40 to 80, any sex, with Colorectal Cancer or Adenomatous Colorectal Polyps. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Recurrent Adenomas at Surveillance Colonoscopy Primary · 3 to 5 years after baseline colonoscopy

Detection of metachronous colorectal adenomas during follow-up, by treatment, in the original cohort. Surveillance colonoscopy is recommended 3 to 5 years after removal of colorectal adenoma(s). Participants will remain on the study intervention until their surveillance colonoscopy. Surveillance colonoscopy is determined by participants' GI physician.

Group	Value	95% CI
Selenium	302
Placebo	295

Median Selenium Blood Levels at One Year. Primary · One year

Adequate adherence to long-term selenium treatment as measured by blood selenium levels (ng/mL) at one year.

Group	Value	95% CI
Selenium	205.4	100.7 – 367.6
Placebo	140.0	84.9 – 270.2

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Selenium

Serious: 228/685 (33%)

Deaths: 11/685

Placebo

Serious: 226/689 (33%)

Deaths: 10/689

Serious adverse events (41 terms)

Reaction	System	Selenium	Placebo
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Misc. cardiac disorders	Cardiac disorders	—	—
Arthritis/Degenerative joint disease	Musculoskeletal and connective tissue disorders	—	—
Misc. renal and urinary disorders	Renal and urinary disorders	—	—
Atrial fibrillation/arrhythmia	Cardiac disorders	—	—
Misc. GI disorders	Gastrointestinal disorders	—	—
Angina	Cardiac disorders	—	—
Chest pain	Cardiac disorders	—	—
Fracture	Musculoskeletal and connective tissue disorders	—	—
Misc. vascular disorders	Vascular disorders	—	—
Stroke/Transient ischemic attack	Nervous system disorders	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—
Infection	Infections and infestations	—	—
Bowel obstruction	Gastrointestinal disorders	—	—
Misc. nervous system disorders	Nervous system disorders	—	—
Misc. musculoskeletal disorders	Musculoskeletal and connective tissue disorders	—	—
GI Bleed	Gastrointestinal disorders	—	—
Misc. respiratory disorders	Respiratory, thoracic and mediastinal disorders	—	—
Myocardial Infarction	Cardiac disorders	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Misc. reproductive and breast disorders	Reproductive system and breast disorders	—	—
Misc. neoplasms	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
COPD	Respiratory, thoracic and mediastinal disorders	—	—
Cellulitis	Infections and infestations	—	—

Most-reported serious reactions: Cancer, Misc. cardiac disorders, Arthritis/Degenerative joint disease, Misc. renal and urinary disorders, Atrial fibrillation/arrhythmia, Misc. GI disorders, Angina, Chest pain.

Data from ClinicalTrials.gov NCT00078897 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis.
Solomon SD, Wittes J, Finn PV, Fowler R, et al · · 2008 · cited 248× · PMID 18378608 · DOI 10.1161/circulationaha.108.764530
Targeting Akt3 signaling in malignant melanoma using isoselenocyanates.
Sharma A, Sharma AK, Madhunapantula SV, Desai D, et al · · 2009 · cited 72× · PMID 19208796 · DOI 10.1158/1078-0432.ccr-08-2214
Selenium Supplementation for Prevention of Colorectal Adenomas and Risk of Associated Type 2 Diabetes.
Thompson PA, Ashbeck EL, Roe DJ, Fales L, et al · · 2016 · cited 69× · PMID 27530657 · DOI 10.1093/jnci/djw152
Celecoxib for the Prevention of Colorectal Adenomas: Results of a Suspended Randomized Controlled Trial.
Thompson PA, Ashbeck EL, Roe DJ, Fales L, et al · · 2016 · cited 42× · PMID 27530656 · DOI 10.1093/jnci/djw151
Selenium supplementation and insulin resistance in a randomized, clinical trial.
Jacobs ET, Lance P, Mandarino LJ, Ellis NA, et al · · 2019 · cited 28× · PMID 30899530 · DOI 10.1136/bmjdrc-2018-000613
Design and baseline characteristics of participants in a phase III randomized trial of celecoxib and selenium for colorectal adenoma prevention.
Thompson P, Roe DJ, Fales L, Buckmeier J, et al · · 2012 · cited 15× · PMID 23060037 · DOI 10.1158/1940-6207.capr-12-0204
A Protective Role for Arachidonic Acid Metabolites against Advanced Colorectal Adenoma in a Phase III Trial of Selenium.
Martinez JA, Skiba MB, Chow HS, Chew WM, et al · · 2021 · cited 14× · PMID 34836131 · DOI 10.3390/nu13113877
Celecoxib use and circulating oxylipins in a colon polyp prevention trial.
Martinez JA, Yang J, Wertheim BC, Roe DJ, et al · · 2018 · cited 7× · PMID 29698447 · DOI 10.1371/journal.pone.0196398

Verify or expand the search:

Other trials of Selenium

Trials testing the same drug.

NCT07334197 — Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy · NA · not yet recruiting
NCT05672095 — Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer · Phase 1, PHASE2 · withdrawn
NCT06413043 — Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy · NA · not yet recruiting
NCT06951282 — Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study · Phase 1, PHASE2 · completed
NCT06362005 — The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus · Phase 4 · completed

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other University of Arizona trials

Trials by the same sponsor.

NCT04062890 — Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance · Phase 2 · withdrawn
NCT05569486 — Elucidating the Central Mechanisms of Action for Green Light Therapy in Managing Chronic Pain · NA · not yet recruiting
NCT05064111 — Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy · suspended
NCT06567899 — Mechanistic Underpinnings of Preeclampsia · not yet recruiting
NCT07254793 — Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00078897 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Arizona
Last refreshed: 24 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00078897.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing