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

Primary Purpose

Selenium Deficiency, Thyroid Cancer TNM Staging, Recurrence

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Selenium Yeast
Placebo
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Selenium Deficiency focused on measuring Selenium, Thyroid Cancer, recurrence, metastasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants have signed informed consent forms;
  2. Patients with differentiated thyroid carcinoma diagnosed pathologically after thyroid surgery;
  3. Male or female patients aged 18-75 years;
  4. 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:

  1. A patient who is pregnant or breastfeeding;
  2. 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);
  3. Gastrointestinal surgery that may affect the study of drug absorption;
  4. The patient has a history of haemoglobin disease or acute progressive nephropathy or autoimmune skin disease;
  5. A history of substance abuse and alcohol abuse within the last 1 year;
  6. There are therapeutic contraindications with selenium yeast capsules as listed in the instructions;
  7. 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;
  8. There are obvious abnormalities in liver function;
  9. The patient has significant liver disease acute active hepatitis or chronic active hepatitis clinical signs or symptoms;
  10. 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;
  11. Patients with severe renal insufficiency.

Sites / Locations

  • The First affiliated hospital of Shandong First Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

experimental group

Placebo control group

No intervention group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

recurrence rate
Percentage

Secondary Outcome Measures

metastasis Rate
Percentage

Full Information

First Posted
November 26, 2020
Last Updated
March 11, 2022
Sponsor
Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04683575
Brief Title
Clinical Study on the Effect of Selenium Yeast Capsule on Prognosis of Differentiated Thyroid Carcinoma
Official Title
Distribution of Selenium in Patients With Differentiated Thyroid Carcinoma and Effect of Selenium Supplement on Prognosis of Patients With Differentiated Thyroid Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2022 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Selenium Deficiency, Thyroid Cancer TNM Staging, Recurrence, Metastasis
Keywords
Selenium, Thyroid Cancer, recurrence, metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
experimental group:Selenium yeast treatment group control group:Placebo control group blank control group
Masking
ParticipantInvestigator
Masking Description
All participants, investigators were blinded to the grouping of the experiment and the intervention.
Allocation
Randomized
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Patients with differentiated thyroid carcinoma with low blood selenium are treated with selenium yeast(dosage form:capsule dosage:200μg bid duration: 5 years).
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
Patients with differentiated thyroid cancer with low blood selenium are given placebo treatment(dosage form:capsule dosage:200μg bid duration: 5 years)
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
Patients with differentiated thyroid cancer with low blood selenium are not treated.
Intervention Type
Drug
Intervention Name(s)
Selenium Yeast
Intervention Description
oral medication
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral medication
Primary Outcome Measure Information:
Title
recurrence rate
Description
Percentage
Time Frame
5 years
Secondary Outcome Measure Information:
Title
metastasis Rate
Description
Percentage
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Liao, Doctor
Phone
18354117713
Email
liaolin@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Liao, Doctor
Organizational Affiliation
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First affiliated hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Cao, PH.D
First Name & Middle Initial & Last Name & Degree
Lin Liao

12. IPD Sharing Statement

Citations:
PubMed Identifier
31960358
Citation
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.
Results Reference
background
PubMed Identifier
29371830
Citation
Metere 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.
Results Reference
background
PubMed Identifier
23350941
Citation
Jonklaas 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.
Results Reference
background
PubMed Identifier
18221503
Citation
Moncayo 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.
Results Reference
background
PubMed Identifier
28412747
Citation
Marshall 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.
Results Reference
background
PubMed Identifier
31997660
Citation
Barrea 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.
Results Reference
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Clinical Study on the Effect of Selenium Yeast Capsule on Prognosis of Differentiated Thyroid Carcinoma

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