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Clinical study on the efficacy and safety of thyroid tablets and levothyroxine sodium tablets in the treatment of postoperative patients with differentiated thyroid cancer

Clinical study on the efficacy and safety of thyroid tablets and levothyroxine sodium tablets in the treatment of postoperative patients with differentiated thyroid cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055714
Enrollment
Unknown
Registered
2022-01-16
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary thyroid carcinoma

Interventions

experimental group:thyroid tablets

Sponsors

The First People's Hospital of Hangzhou Affiliated to Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Patients with differentiated thyroid cancer (DTC) diagnosed by pathological examination and belonging to ATA low-risk group with TSH inhibition target value below 0.5; 3. Thyroid cancer surgery, lymph node dissection in the central area of the affected side or modified neck lymph node dissection, etc; 4. Patients voluntarily participated and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with pathological diagnosis of Schutter cell carcinoma or undifferentiated thyroid carcinoma, including medullary thyroid carcinoma (MTC) or undifferentiated thyroid carcinoma (anaplastic thyroid carcinoma) (ATC); 2. Patients with other thyroid diseases, such as hyperthyroidism or toxic nodular goiter; 3. Known gastrointestinal diseases (gastrointestinal malabsorption, such as gastritis related to Helicobacter pylori infection, atrophic gastritis, celiac disease, lactose intolerance, etc., or a history of gastric bypass surgery); 4. Patients with contraindications to levothyroxine sodium tablets and thyroid tablets; 5. Serious dysfunction of heart, kidney, liver, respiratory tract, pituitary and other important organs or history of major diseases (such as serious cardiovascular damage, arrhythmia, etc.); 6. Suffering from serious mental illness or having a history of mental disorders; 7. Pregnant or lactating patients; 8. Suffering from chronic diseases such as autoimmune diseases; 9. Drugs that interfere with the absorption or metabolism of levothyroxine sodium tablets or thyroid tablets are currently being used (e.g., estrogen and testosterone, iodine, propranolol, amiodarone, dopamine agonists or antagonists, somatostatin analogues, steroids, phenytoin sodium, proton pump inhibitors, etc.); 10. Left thyroxine sodium tablets or thyroid tablets or T3 preparations have been used before.

Design outcomes

Primary

MeasureTime frame
Total clinical response rate at week 24;

Secondary

MeasureTime frame
Percentage of patients whose serum TSH levels reached the target, mean TSH and changes from baseline in the two groups;Thyroid function evaluation (FT3, FT4 levels) of patients in two groups;Changes of clinical symptom scores in the two groups from baseline;

Countries

China

Contacts

Public ContactPeng You

The First People's Hospital of Hangzhou Affiliated to Zhejiang University School of Medicine

doctor3663@163.com+86 13666600944

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026