Clinical Study on the Effect of Selenium Yeast Capsule on Prognosis of Differentiated Thyroid Carcinoma

Sponsor

Qianfoshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04683575

Collaborator

(none)

5,000

Enrollment

Location

Arms

42.1

Anticipated Duration (Months)

118.8

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Selenium Deficiency Thyroid Cancer TNM Staging Recurrence Metastasis	Drug: Selenium Yeast Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

experimental group：Selenium yeast treatment group control group：Placebo control group blank control groupexperimental group：Selenium yeast treatment group control group：Placebo control group blank control group

Masking:

Double (Participant, Investigator)

Masking Description:

All participants, investigators were blinded to the grouping of the experiment and the intervention.

Primary Purpose:

Treatment

Official Title:

Distribution of Selenium in Patients With Differentiated Thyroid Carcinoma and Effect of Selenium Supplement on Prognosis of Patients With Differentiated Thyroid Carcinoma.

Anticipated Study Start Date :

May 30, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group Patients with differentiated thyroid carcinoma with low blood selenium are treated with selenium yeast（dosage form：capsule dosage：200μg bid duration: 5 years）.	Drug: Selenium Yeast oral medication
Placebo Comparator: Placebo control group Patients with differentiated thyroid cancer with low blood selenium are given placebo treatment（dosage form：capsule dosage：200μg bid duration: 5 years）	Drug: Placebo oral medication
No Intervention: No intervention group Patients with differentiated thyroid cancer with low blood selenium are not treated.

Arm

Intervention/Treatment

Experimental: experimental group

Patients with differentiated thyroid carcinoma with low blood selenium are treated with selenium yeast（dosage form：capsule dosage：200μg bid duration: 5 years）.

Drug: Selenium Yeast

oral medication

Placebo Comparator: Placebo control group

Patients with differentiated thyroid cancer with low blood selenium are given placebo treatment（dosage form：capsule dosage：200μg bid duration: 5 years）

Drug: Placebo

oral medication

No Intervention: No intervention group

Patients with differentiated thyroid cancer with low blood selenium are not treated.

Outcome Measures

Primary Outcome Measures

recurrence rate [5 years]
Percentage

Secondary Outcome Measures

metastasis Rate [5 years]
Percentage

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.