NCT01497431

Phase I Multiple Dose Study of 12-Week Treatment by Se-Methyl-L-Cysteine(MSC) and L SeMet in Adult Males

Completed Phase 1 Last updated 25 November 2014

What this trial tests

Phase 1 trial testing Selenium in No Evidence of Disease in 66 participants. Completed in 1 July 2014.

Timeline

1 November 2011

Primary endpoint
1 June 2014

1 July 2014

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	66
Start date	1 November 2011
Primary completion	1 June 2014
Estimated completion	1 July 2014
Sites	3 locations across United States

Drugs / interventions tested

• Selenium (SELENIUM) — full drug profile →
• Placebo
• Laboratory Biomarker Analysis — full drug profile →
• Pharmacological Study — full drug profile →
• Methylselenocysteine — full drug profile →

Conditions studied

• No Evidence of Disease — all drugs for No Evidence of Disease →
• Prostate Carcinoma — all drugs for Prostate Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 40 to 80, male only, with No Evidence of Disease or Prostate Carcinoma. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Clinical toxicity of Se-methyl-seleno-L-cysteine according to the NCI CTCAE version 4.0
  Time frame: Up to 112 days
  The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.
• Clinical toxicity of Se-methyl-L-cysteine compared to selenium after multiple doses, according to the NCI CTCAE version 4.0
  Time frame: Up to 112 days
  The safety and tolerability data will be summarized using descriptive statistics, by cohort and for all cohorts combined compared to placebo. Reported adverse events will be looked at for possible differences, where appropriate, using graphical methods.

Sponsor's own description

This randomized phase I trial studies the side effects and the best dose of Se-methyl-seleno-L-cysteine or selenomethionine in preventing prostate cancer in healthy participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Se-methyl-seleno-L-cysteine or selenomethionine, two different types of selenium compounds, may prevent prostate cancer from forming.

Publications & conference data

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

1. Selenium Compounds as Novel Potential Anticancer Agents.
   Radomska D, Czarnomysy R, Radomski D, Bielawski K. · · 2021 · cited 97× · PMID 33498364 · DOI 10.3390/ijms22031009
2. Selenium as a Bioactive Micronutrient in the Human Diet and Its Cancer Chemopreventive Activity.
   Radomska D, Czarnomysy R, Radomski D, Bielawska A, et al · · 2021 · cited 63× · PMID 34068374 · DOI 10.3390/nu13051649
3. Thioredoxin (Trx): A redox target and modulator of cellular senescence and aging-related diseases.
   Yang B, Lin Y, Huang Y, Shen YQ, et al · · 2024 · cited 39× · PMID 38232457 · DOI 10.1016/j.redox.2024.103032
4. Selenium-Containing Agents Acting on Cancer-A New Hope?
   Garbo S, Di Giacomo S, Łażewska D, Honkisz-Orzechowska E, et al · · 2022 · cited 29× · PMID 36678733 · DOI 10.3390/pharmaceutics15010104
5. Searching for Low Molecular Weight Seleno-Compounds in Sprouts by Mass Spectrometry.
   Kurek E, Michalska-Kacymirow M, Konopka A, Kościuczuk O, et al · · 2020 · cited 6× · PMID 32580370 · DOI 10.3390/molecules25122870
6. Advances in Selenium and Related Compounds Inhibiting Multi-Organ Fibrosis.
   Xiao X, Huang G, Yu X, Tan Y. · · 2025 · cited 3× · PMID 39830783 · DOI 10.2147/dddt.s488226
7. Differential Inhibition of Anaplerotic Pyruvate Carboxylation and Glutaminolysis-Fueled Anabolism Underlies Distinct Toxicity of Selenium Agents in Human Lung Cancer.
   Fan TW, Winnike J, Al-Attar A, Belshoff AC, et al · · 2023 · cited 3× · PMID 37512481 · DOI 10.3390/metabo13070774
8. Selenomethionine alleviates aortic dissection via PGC-1α/NRF2/TFAM-mediated mitochondrial biosynthesis against ferroptosis: an experimental study.
   Lai S, Qin H, Wang X, Bi Y, et al · · 2026 · cited 1× · PMID 41208796 · DOI 10.1097/js9.0000000000003561