Thyroid Cancer
Conditions
Keywords
Levothyroxine, Pharmacokinetics, Pharmacodynamics
Brief summary
Through pharmacometric approaches-including modeling, mathematics, and statistics-this work aims to refine the levothyroxine sodium tablet (brand name: Euthyrox) dosing strategy in post-thyroidectomy cancer patients, enabling individualized precision dosing to minimize side effects and maximize therapeutic outcomes.
Interventions
None listed
Sponsors
Zhejiang Provincial People's Hospital
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-65 years, inclusive, regardless of sex. * Able to fully understand the study and voluntarily sign the informed consent form. * Histologically or cytologically confirmed advanced or metastatic thyroid cancer, treatment-naïve, and requiring total or near-total thyroidectomy. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * No clinically significant contraindications to surgery. * Body weight ≥50.0 kg for males and ≥45.0 kg for females, with a body mass index (BMI) of 19.0-26.0 kg/m², inclusive. * Able to maintain regular daily routines, communicate effectively with the investigator, comply with all study requirements, and adhere to scheduled study visits, treatment plans, and laboratory assessments. * Adequate baseline organ function at the screening visit, as demonstrated by local laboratory values meeting the protocol-specified eligibility requirements.
Exclusion criteria
* Thyroid cancer patients for whom the planned or completed thyroidectomy does not meet the criteria for total or near-total thyroidectomy. * Prior treatment for thyroid cancer, including surgery and/or pharmacological treatment. * Major surgery, including radiosurgery, or significant traumatic injury within 2 weeks prior to randomization. * History of another malignancy within 3 years prior to initiation of study treatment. * Known history of a positive human immunodeficiency virus (HIV) test. * Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; chronic or resolved HBV or HCV infection is permitted. * Congenital or acquired immunodeficiency. * History of clinically significant drug allergy or atopic allergic disease (e.g., asthma, urticaria, or eczematous dermatitis), or known hypersensitivity to Euthyrox (levothyroxine sodium) or any of its excipients. * Pregnant or breastfeeding females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TFT panel (TSH, FT3, FT4, TT3, TT4, TPOAb, TGAb) | Preoperatively after enrollment, 19:00 on the day of surgery, and before medication on postoperative day 1 (patients accurately recorded the administration time to the minute; the medication time was set at 7:00), 7:30, 8:00, 8:30, and 9:00 on postoperat | Using mathematical and statistical methods (PopPK/PD) grounded in quantitative pharmacology to quantitatively describe, explain, and predict drug effects in vivo. |
Countries
China
Outcome results
None listed