Selenium DeficiencyPhase 4NCT04683575
Clinical Study on the Effect of Selenium Yeast Capsule on Prognosis of Differentiated Thyroid Carcinoma
A Phase 4 study testing Selenium Yeast in people with Selenium Deficiency and Thyroid Cancer TNM Staging, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Oxidative stress is involved in the pathogenesis of thyroid cancer, but the mechanism is not clear. The thyroid is the organ with the most abundant selenium content, and selenium may be involved in protecting the gland from the influence of large amounts of H2O2 produced during thyroid hormone biosynthesis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Selenium Deficiency, Thyroid Cancer TNM Staging, Recurrence
- What is being tested?
- Selenium Yeast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants have signed informed consent forms；
- Patients with differentiated thyroid carcinoma diagnosed pathologically after thyroid surgery；
- Male or female patients aged 18-75 years;
- Women who are likely to become pregnant must use the appropriate contraceptive method to avoid pregnancy and minimize the likelihood of conception between the beginning of the drug intervention study and the 28th day after the study.
Who cannot join
- A patient who is pregnant or breastfeeding;
- Currently, hepatase cytochrome P450 3A4 induction or inhibitor therapy, antiviral therapy for immunodeficiency diseases (note: hepatase induction or inhibitor: phenobarbital phenobarbital sodium rifampicin carbamazepine grisoflomycin and dexamethasone and chloramphenicol allopurinol ketone conazole isoniazid imittidine phenothiazine);
- Gastrointestinal surgery that may affect the study of drug absorption;
- The patient has a history of haemoglobin disease or acute progressive nephropathy or autoimmune skin disease;
- A history of substance abuse and alcohol abuse within the last 1 year;
- There are therapeutic contraindications with selenium yeast capsules as listed in the instructions;
Show all 11Show fewer
- New York Heart Association (NYHA) class III or IV congestive heart failure and/or left ventricular ejection fraction of 40% with a significant cardiovascular history in the past 6 months: myocardial infarction coronary angioplasty or bypass surgery valvular disease or repair of unstable angina transient ischemic attack or cerebrovascular accident;
- There are obvious abnormalities in liver function;
- The patient has significant liver disease acute active hepatitis or chronic active hepatitis clinical signs or symptoms；
- Laboratory and physical examination or ECG findings of any clinically significant abnormality would, in the investigator's judgment, compromise the patient's safety or prevent successful participation in the clinical study；
- Patients with severe renal insufficiency.
Trial locations and contacts
1 site in 1 country.
China1 site
The First affiliated hospital of Shandong First Medical University
Jinan, Shandong, 250000
Lili Cao, PH.D
Lin Liao
About this study
Official title: Distribution of Selenium in Patients With Differentiated Thyroid Carcinoma and Effect of Selenium Supplement on Prognosis of Patients With Differentiated Thyroid Carcinoma.
Oxidative stress is involved in the pathogenesis of thyroid cancer, but the mechanism is not clear. The thyroid is the organ with the most abundant selenium content, and selenium may be involved in protecting the gland from the influence of large amounts of H2O2 produced during thyroid hormone biosynthesis.
Selenium may exert anti-tumor activity through a variety of mechanisms, including inducing apoptosis and anti-oxidation to change the DNA methylation state of tumor suppressor genes, cell cycle arrest and stimulation of the immune system, as well as playing an anti-tumor role through its anti-inflammatory and anti-angiogenesis properties.
Read more
The whole blood and thyroid selenium concentrations in patients with thyroid cancer were lower, and the decreased serum selenium levels were also associated with the high TNM stage of thyroid cancer.
According to the Nutrition Prevention of Cancer (NPC) trial, selenium yeast supplements with a daily selenium content of 200 MCG have been shown to reduce the incidence of total cancer, prostate cancer, colon cancer, and lung cancer, and cancer mortality. The active agent in selenium yeast supplements is known as selenium methionine (SEMET).
In general, the association between selenium and thyroid cancer is still inconclusive, the question of whether low selenium is a predisposition factor or a consequence of thyroid cancer has not been resolved, and the clinical effect of selenium supplementation in preventing thyroid cancer or improving its prognosis remains to be studied.
The hypothesis is that supplementation with selenium yeast will improve the prognosis of patients with differentiated alpha-carcinoma.
- Being tested
- Selenium Yeast, Placebo
- Keywords
- Selenium, Thyroid Cancer, recurrence, metastasis
- Medical subject headings
- Recurrence, Neoplasm Metastasis, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium YeastDrug
oral medication
PlaceboDrug
oral medication
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients with differentiated thyroid carcinoma with low blood selenium are treated with selenium yeast（dosage form：capsule dosage：200μg bid duration: 5 years）. Receives: Drug: Selenium Yeast |
| Placebo control group | Placebo comparator | Patients with differentiated thyroid cancer with low blood selenium are given placebo treatment（dosage form：capsule dosage：200μg bid duration: 5 years） Receives: Drug: Placebo |
| No intervention group | No intervention | Patients with differentiated thyroid cancer with low blood selenium are not treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
Percentage
Measured: 5 years
Secondary outcomes (1)
metastasis Rate
Percentage
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start30 May 2022 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Selenium DeficiencyStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental group：Selenium yeast treatment group control group：Placebo control group blank control group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Lin Liao, Doctor, Principal investigator, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683575
- Sponsor's protocol ID
- XYJA2020
- Status last verified
- Mar 2022
- First submitted
- 26 Nov 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gheorghiu ML, Badiu C. Selenium involvement in mitochondrial function in thyroid disorders. Hormones (Athens). 2020 Mar;19(1):25-30. doi: 10.1007/s42000-020-00173-2. Epub 2020 Jan 20.
PubMed 31960358Metere A, Frezzotti F, Graves CE, Vergine M, De Luca A, Pietraforte D, Giacomelli L. A possible role for selenoprotein glutathione peroxidase (GPx1) and thioredoxin reductases (TrxR1) in thyroid cancer: our experience in thyroid surgery. Cancer Cell Int. 2018 Jan 15;18:7. doi: 10.1186/s12935-018-0504-4. eCollection 2018.
PubMed 29371830Jonklaas J, Danielsen M, Wang H. A pilot study of serum selenium, vitamin D, and thyrotropin concentrations in patients with thyroid cancer. Thyroid. 2013 Sep;23(9):1079-86. doi: 10.1089/thy.2012.0548. Epub 2013 Jul 17.
PubMed 23350941Moncayo R, Kroiss A, Oberwinkler M, Karakolcu F, Starzinger M, Kapelari K, Talasz H, Moncayo H. The role of selenium, vitamin C, and zinc in benign thyroid diseases and of selenium in malignant thyroid diseases: Low selenium levels are found in subacute and silent thyroiditis and in papillary and follicular carcinoma. BMC Endocr Disord. 2008 Jan 25;8:2. doi: 10.1186/1472-6823-8-2.
PubMed 18221503Marshall JR, Burk RF, Payne Ondracek R, Hill KE, Perloff M, Davis W, Pili R, George S, Bergan R. Selenomethionine and methyl selenocysteine: multiple-dose pharmacokinetics in selenium-replete men. Oncotarget. 2017 Apr 18;8(16):26312-26322. doi: 10.18632/oncotarget.15460.
PubMed 28412747Barrea L, Gallo M, Ruggeri RM, Giacinto PD, Sesti F, Prinzi N, Adinolfi V, Barucca V, Renzelli V, Muscogiuri G, Colao A, Baldelli R; E.O.L.O. Group. Nutritional status and follicular-derived thyroid cancer: An update. Crit Rev Food Sci Nutr. 2021;61(1):25-59. doi: 10.1080/10408398.2020.1714542. Epub 2020 Jan 30.
PubMed 31997660
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Selenium in Patients With Differentiated Thyroid Carcinoma and Effect of Selenium Supplement on Prognosis of Patients With Differentiated Thyroid Carcinoma.
- ClinicalTrials.gov ID
- NCT04683575
- Acronym / sponsor ID
- XYJA2020
- Keywords
- Selenium, Thyroid Cancer, recurrence, metastasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 30 May 2022 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxidative stress is involved in the pathogenesis of thyroid cancer, but the mechanism is not clear. The thyroid is the organ with the most abundant selenium content, and selenium may be involved in protecting the gland from the influence of large amounts of H2O2 produced during thyroid hormone biosynthesis.
Selenium may exert anti-tumor activity through a variety of mechanisms, including inducing apoptosis and anti-oxidation to change the DNA methylation state of tumor suppressor genes, cell cycle arrest and stimulation of the immune system, as well as playing an anti-tumor role through its anti-inflammatory and anti-angiogenesis properties.
The whole blood and thyroid selenium concentrations in patients with thyroid cancer were lower, and the decreased serum selenium levels were also associated with the high TNM stage of thyroid cancer.
According to the Nutrition Prevention of Cancer (NPC) trial, selenium yeast supplements with a daily selenium content of 200 MCG have been shown to reduce the incidence of total cancer, prostate cancer, colon cancer, and lung cancer, and cancer mortality. The active agent in selenium yeast supplements is known as selenium methionine (SEMET).
In general, the association between selenium and thyroid cancer is still inconclusive, the question of whether low selenium is a predisposition factor or a consequence of thyroid cancer has not been resolved, and the clinical effect of selenium supplementation in preventing thyroid cancer or improving its prognosis remains to be studied.
The hypothesis is that supplementation with selenium yeast will improve the prognosis of patients with differentiated alpha-carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- experimental group：Selenium yeast treatment group control group：Placebo control group blank control group
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Selenium YeastPatients with differentiated thyroid carcinoma with low blood selenium are treated with selenium yeast（dosage form：capsule dosage：200μg bid duration: 5 years）. |
| Placebo control group | Placebo comparator | Drug: PlaceboPatients with differentiated thyroid cancer with low blood selenium are given placebo treatment（dosage form：capsule dosage：200μg bid duration: 5 years） |
| No intervention group | No intervention | –Patients with differentiated thyroid cancer with low blood selenium are not treated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants have signed informed consent forms；
- Patients with differentiated thyroid carcinoma diagnosed pathologically after thyroid surgery；
- Male or female patients aged 18-75 years;
- Women who are likely to become pregnant must use the appropriate contraceptive method to avoid pregnancy and minimize the likelihood of conception between the beginning of the drug intervention study and the 28th day after the study.
Key exclusion criteria (11 listed)
- A patient who is pregnant or breastfeeding;
- Currently, hepatase cytochrome P450 3A4 induction or inhibitor therapy, antiviral therapy for immunodeficiency diseases (note: hepatase induction or inhibitor: phenobarbital phenobarbital sodium rifampicin carbamazepine grisoflomycin and dexamethasone and chloramphenicol allopurinol ketone conazole isoniazid imittidine phenothiazine);
- Gastrointestinal surgery that may affect the study of drug absorption;
- The patient has a history of haemoglobin disease or acute progressive nephropathy or autoimmune skin disease;
- A history of substance abuse and alcohol abuse within the last 1 year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium Yeastoral medication | Drug | experimental group |
| Placebooral medication | Drug | Placebo control group |
Primary outcome
recurrence rate
Time frame: 5 years
Percentage
1 secondary outcome
metastasis Rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Background: PubMed 31960358Gheorghiu ML, Badiu C. Selenium involvement in mitochondrial function in thyroid disorders. Hormones (Athens). 2020 Mar;19(1):25-30. doi: 10.1007/s42000-020-00173-2. Epub 2020 Jan 20.
- Background: PubMed 29371830Metere A, Frezzotti F, Graves CE, Vergine M, De Luca A, Pietraforte D, Giacomelli L. A possible role for selenoprotein glutathione peroxidase (GPx1) and thioredoxin reductases (TrxR1) in thyroid cancer: our experience in thyroid surgery. Cancer Cell Int. 2018 Jan 15;18:7. doi: 10.1186/s12935-018-0504-4. eCollection 2018.
- Background: PubMed 23350941Jonklaas J, Danielsen M, Wang H. A pilot study of serum selenium, vitamin D, and thyrotropin concentrations in patients with thyroid cancer. Thyroid. 2013 Sep;23(9):1079-86. doi: 10.1089/thy.2012.0548. Epub 2013 Jul 17.
- Background: PubMed 18221503Moncayo R, Kroiss A, Oberwinkler M, Karakolcu F, Starzinger M, Kapelari K, Talasz H, Moncayo H. The role of selenium, vitamin C, and zinc in benign thyroid diseases and of selenium in malignant thyroid diseases: Low selenium levels are found in subacute and silent thyroiditis and in papillary and follicular carcinoma. BMC Endocr Disord. 2008 Jan 25;8:2. doi: 10.1186/1472-6823-8-2.
- Background: PubMed 28412747Marshall JR, Burk RF, Payne Ondracek R, Hill KE, Perloff M, Davis W, Pili R, George S, Bergan R. Selenomethionine and methyl selenocysteine: multiple-dose pharmacokinetics in selenium-replete men. Oncotarget. 2017 Apr 18;8(16):26312-26322. doi: 10.18632/oncotarget.15460.
- Background: PubMed 31997660Barrea L, Gallo M, Ruggeri RM, Giacinto PD, Sesti F, Prinzi N, Adinolfi V, Barucca V, Renzelli V, Muscogiuri G, Colao A, Baldelli R; E.O.L.O. Group. Nutritional status and follicular-derived thyroid cancer: An update. Crit Rev Food Sci Nutr. 2021;61(1):25-59. doi: 10.1080/10408398.2020.1714542. Epub 2020 Jan 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Liao, Doctor principal investigator
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selenium Yeast in people with Selenium Deficiency and Thyroid Cancer TNM Staging, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Liao, Doctor (18354117713, liaolin@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04683575, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.