Clinical trial · Interventional
Prevention of Female Cancers by Optimization of Selenium Levels in the Organism.
Prevention of Females Malignancies in Families With Hereditary Breast Cancer by Personalized Optimization of Se Levels in the Organism.
NCT04014283CI-TRIAL-00065816SELINAunknownN/AClinicalTrials.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)
Hypothesis to be tested: Oral supplementation or diet modifications of selenium to a specified range will be effective in reducing the risk of developing cancer of any type in women with high risk of breast cancer, as compared to placebo.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet modification | Other | — | UNRESOLVED |
| Selenium supplementation or placebo treatment | Dietary Supplement | — | UNRESOLVED |
| Selenium supplementation or placebo treatment and diet modification | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- BRCA(+) Selenium deficiency
- description
- Placebo: 100 Supplement: 100
- interventionNames
- Dietary Supplement: Selenium supplementation or placebo treatment
- type
- ACTIVE_COMPARATOR
- label
- BRCA(+) Selenium excess
- description
- Diet modification: 500 Observation: 500
- interventionNames
- Other: Diet modification
- type
- ACTIVE_COMPARATOR
- label
- BRCA(-) Selenium deficiency
- description
- Placebo: 900 Supplement: 900 Diet modification: 900 Observation: 900
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: \- Sub-group I - BRCA1 mutation carriers 1. Carrier-status of BRCA1 mutation 2. Age \>20 years 3. Have a breast magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment 4. Be able to give information consent and sign an informed consent form 5. Be willing to comply with all of the study procedures as per the protocol 6. Be willing to inform researchers about current or any new pregnancy 7. Sub-optimal Se level in the blood Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations 1. Age ≥40 years 2. Age ≥20 years for women that have been diagnosed previously with breast cancer 3. Positive medical history of family, matching criteria of hereditary breast/ovarian cancer (HBO) (Appendix 1) 4. No personal history of cancer except for breast cancer and non-melanoma skin cancers 5. Have a breast magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment 6. Be able to give information consent and sign an informed consent form 7. Absence of BRCA1 mutations after testing for at least three founder mutations (BRCA1 5382insC, BRCA1 300T/G, BRCA1 4154delA) 8. Be willing to comply with all of the study procedures as per the protocol 9. Be willing to inform researchers about current or any new pregnancy 10. Sub-optimal Se level in the blood Exclusion Criteria: Sub-group I - BRCA1 mutation carriers 1. Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers 2. Absence of a magnetic resonance imaging/ultrasonography/mammography that reveals no disease at maximum 9 months after enrollment 3. Current pregnancy or breast-feeding 4. Optimal Se level in the blood 5. Age \<20 years 6. Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy 7. Participation in any other clinical study involving a medical, surgical, nutritional, or life-style intervention (unless individuals are no longer receiving any intervention and they are in the follow-up phase only) Sub-group II - Females from families with hereditary breast cancers but without BRCA1 mutations 1. Diagnosis of any previous cancer except for breast cancers and non-melanoma skin cancers 2. Absence of magnetic resonance imaging and/or ultrasonography and/or mammography that reveals no disease at maximum 9 months after enrollment 3. Absence of matching pedigree/clinical/molecular criteria of HBO (Appendix 1) 4. Presence of BRCA1 mutation 5. Current pregnancy or breast-feeding 6. Optimal Se level in the blood 7. Age \<40 years except for women that have been previously diagnosed with breast cancer 8. Any medical illness, which, in the investigator's opinion, cannot be adequately controlled with appropriate therapy 9. Participation in any other clinical study involving a medical, surgical, nutritional, or life-style intervention (unless individuals are no longer receiving any intervention and they are in the follow-up phase only)
References
Publications (67)
- BACKGROUNDAdeoti ML, Oguntola AS, Akanni EO, Agodirin OS, Oyeyemi GM. Trace elements; copper, zinc and selenium, in breast cancer afflicted female patients in LAUTECH Osogbo, Nigeria. Indian J Cancer. 2015 Jan-Mar;52(1):106-9. doi: 10.4103/0019-509X.175573. PMID 26837992
- BACKGROUNDAlgotar AM, Behnejad R, Singh P, Thompson PA, Hsu CH, Stratton SP. EFFECT OF SELENIUM SUPPLEMENTATION ON PROTEOMIC SERUM BIOMARKERS IN ELDERLY MEN. J Frailty Aging. 2015;4(2):107-10. doi: 10.14283/jfa.2015.48. PMID 26366377
- BACKGROUNDArnaud J, Arnault N, Roussel AM, Bertrais S, Ruffieux D, Galan P, Favier A, Hercberg S. Relationships between selenium, lipids, iron status and hormonal therapy in women of the SU.VI.M.AX cohort. J Trace Elem Med Biol. 2007;21 Suppl 1:66-9. doi: 10.1016/j.jtemb.2007.09.025. Epub 2007 Oct 22. PMID 18039502
- BACKGROUNDBarany E, Bergdahl IA, Bratteby LE, Lundh T, Samuelson G, Skerfving S, Oskarsson A. Iron status influences trace element levels in human blood and serum. Environ Res. 2005 Jun;98(2):215-23. doi: 10.1016/j.envres.2004.09.010. PMID 15820728
- BACKGROUNDSingh BP, Dwivedi S, Dhakad U, Murthy RC, Choubey VK, Goel A, Sankhwar SN. Status and Interrelationship of Zinc, Copper, Iron, Calcium and Selenium in Prostate Cancer. Indian J Clin Biochem. 2016 Mar;31(1):50-6. doi: 10.1007/s12291-015-0497-x. Epub 2015 Apr 16. PMID 26855488
- BACKGROUNDBleys J, Navas-Acien A, Guallar E. Serum selenium levels and all-cause, cancer, and cardiovascular mortality among US adults. Arch Intern Med. 2008 Feb 25;168(4):404-10. doi: 10.1001/archinternmed.2007.74. PMID 18299496
- BACKGROUNDBorawska MH, Socha K, Lazarczyk B, Czyzewska E, Markiewicz R, Darewicz B. The effects of diet on selenium concentration in serum in patients with cancer. Nutr Cancer. 2009;61(5):629-33. doi: 10.1080/01635580902825555.