Status:
UNKNOWN
Clinical Study on the Effect of Selenium Yeast Capsule on Prognosis of Differentiated Thyroid Carcinoma
Lead Sponsor:
Qianfoshan Hospital
Conditions:
Selenium Deficiency
Thyroid Cancer TNM Staging
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 pr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT04683575
Start Date
May 30 2022
End Date
December 1 2025
Last Update
March 14 2022
Active Locations (1)
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1
The First affiliated hospital of Shandong First Medical University
Jinan, Shandong, China, 250000