Two thyroid hormone medicines versus one in advanced thyroid cancer patients on targeted drugs

Who can take part

• Age ≥18 and <80 years
• Patients with a diagnosis of locally advanced/metastatic progressive thyroid cancer, on LT4 therapy, eligible for TKI treatment
• Circulating TSH levels between 0.1 and 4 mIU/L
• ECOG performance status ≤2, with no sudden deterioration in the two weeks prior to the start of the study
• Patients able to understand the full nature and purpose of the study, including potential risks and side effects, able to comply with study procedures, and meet all study requirements according to the investigator’s judgment

Who cannot take part

• Use of drugs interfering with peripheral thyroid hormone metabolism or known type 2 deiodinase inhibitors (e.g., amiodarone, propranolol, corticosteroids) and psychotropic medications
• Treatment with psychotropic drugs, anxiolytics, or mood stabilizers
• Hypersensitivity to the investigational medicinal product or its excipients
• Clinically significant active malabsorption syndrome or other conditions affecting gastrointestinal drug absorption
• Psychiatric diagnosis of mood disorder or other known psychiatric conditions
• Clinically significant active cardiovascular disease (e.g., NYHA class III/IV heart failure) or history of myocardial infarction
• Uncontrolled atrial fibrillation or clinically significant arrhythmias in the past 6 months
• Epatic insufficiency (total bilirubin >2.0 mg/dL, albumin <3.5 g/dL, INR >1.7, ascites, portosystemic encephalopathy) and/or renal insufficiency (eGFR <30 mL/min)
• Pregnancy or breastfeeding
• Participation in other clinical studies
• Symptomatic primary central nervous system tumor or symptomatic CNS metastases