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

Last updated: March 11, 2022
Sponsor: Qianfoshan Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Neoplasm Metastasis

Cancer

Treatment

N/A

Clinical Study ID

NCT04683575
XYJA2020
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants have signed informed consent forms;
  2. Patients with differentiated thyroid carcinoma diagnosed pathologically after thyroidsurgery;
  3. Male or female patients aged 18-75 years;
  4. Women who are likely to become pregnant must use the appropriate contraceptive methodto avoid pregnancy and minimize the likelihood of conception between the beginning ofthe drug intervention study and the 28th day after the study.

Exclusion

Exclusion Criteria:

  1. A patient who is pregnant or breastfeeding;
  2. Currently, hepatase cytochrome P450 3A4 induction or inhibitor therapy, antiviraltherapy for immunodeficiency diseases (note: hepatase induction or inhibitor:phenobarbital phenobarbital sodium rifampicin carbamazepine grisoflomycin anddexamethasone and chloramphenicol allopurinol ketone conazole isoniazid imittidinephenothiazine);
  3. Gastrointestinal surgery that may affect the study of drug absorption;
  4. The patient has a history of haemoglobin disease or acute progressive nephropathy orautoimmune 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 theinstructions;
  7. New York Heart Association (NYHA) class III or IV congestive heart failure and/or leftventricular ejection fraction of 40% with a significant cardiovascular history in thepast 6 months: myocardial infarction coronary angioplasty or bypass surgery valvulardisease or repair of unstable angina transient ischemic attack or cerebrovascularaccident;
  8. There are obvious abnormalities in liver function;
  9. The patient has significant liver disease acute active hepatitis or chronic activehepatitis clinical signs or symptoms;
  10. Laboratory and physical examination or ECG findings of any clinically significantabnormality would, in the investigator's judgment, compromise the patient's safety orprevent successful participation in the clinical study;
  11. Patients with severe renal insufficiency.

Study Design

Total Participants: 5000
Study Start date:
May 30, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • The First affiliated hospital of Shandong First Medical University

    Jinan, Shandong 250000
    China

    Site Not Available

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