Prospective, multicenter, randomized study on combined LT4 + LT3 therapy versus LT4 in the control of TSH in patients with advanced thyroid cancer treated with tyrosine kinase inhibitors.

Conditions

Advanced thyroid carcinoma. Post-thyroidectomy hypothyroidism.

Brief summary

Number and proportion of patients in each group who maintain TSH within the target range (0.1–0.5 mIU/L) throughout the study without any dose adjustments of LT4 and/or LT3.

Detailed description

Absolute change from baseline in serum FT3 and FT4 concentrations (ΔFT3, ΔFT4) at weeks 4, 12, and 24 after TKI initiation., Absolute change from baseline in EORTC QLQ–C30 v3.0 questionnaire scores at weeks 4, 12, and 24 after TKI initiation., Change from baseline in LDL cholesterol at weeks 4, 12, and 24 after TKI initiation., Association between changes in serum thyroid hormone levels and the Thr92Ala polymorphism of the DIO2 gene., Treatment safety, with reference to the duration of excessive TSH suppression (TSH <0.1 mIU/L) and time spent outside the target range (TSH >0.5 mIU/L)., Time to first TSH deviation above the target range (TSH >0.5 mIU/L) after the initiation of TKI., Percentage of time serum TSH values remain within the target range (0.1–0.5 mIU/L) after the initiation of TKI.

Related papers

No related papers found yet.

Interventions

DRUGLEVOTIRSOL 100 microgrammi soluzione orale in contenitore monodose

DRUGEUTIROX 100 microgrammi compresse

DRUGLiotir 15 microgrammi/ml soluzione orale

DRUGLiotir 20 microgrammi/ml soluzione orale

DRUGLiotir 20 microgrammi/ml gocce orali

DRUGsoluzione

DRUGLiotir 5 microgrammi/ml soluzione orale

DRUGLiotir 10 microgrammi/ml soluzione orale

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number and proportion of patients in each group who maintain TSH within the target range (0.1–0.5 mIU/L) throughout the study without any dose adjustments of LT4 and/or LT3.	—

Secondary

Measure	Time frame
Absolute change from baseline in serum FT3 and FT4 concentrations (ΔFT3, ΔFT4) at weeks 4, 12, and 24 after TKI initiation., Absolute change from baseline in EORTC QLQ–C30 v3.0 questionnaire scores at weeks 4, 12, and 24 after TKI initiation., Change from baseline in LDL cholesterol at weeks 4, 12, and 24 after TKI initiation., Association between changes in serum thyroid hormone levels and the Thr92Ala polymorphism of the DIO2 gene., Treatment safety, with reference to the duration of excessive TSH suppression (TSH <0.1 mIU/L) and time spent outside the target range (TSH >0.5 mIU/L)., Time to first TSH deviation above the target range (TSH >0.5 mIU/L) after the initiation of TKI., Percentage of time serum TSH values remain within the target range (0.1–0.5 mIU/L) after the initiation of TKI.	—

Measure

Time frame

Absolute change from baseline in serum FT3 and FT4 concentrations (ΔFT3, ΔFT4) at weeks 4, 12, and 24 after TKI initiation., Absolute change from baseline in EORTC QLQ–C30 v3.0 questionnaire scores at weeks 4, 12, and 24 after TKI initiation., Change from baseline in LDL cholesterol at weeks 4, 12, and 24 after TKI initiation., Association between changes in serum thyroid hormone levels and the Thr92Ala polymorphism of the DIO2 gene., Treatment safety, with reference to the duration of excessive TSH suppression (TSH <0.1 mIU/L) and time spent outside the target range (TSH >0.5 mIU/L)., Time to first TSH deviation above the target range (TSH >0.5 mIU/L) after the initiation of TKI., Percentage of time serum TSH values remain within the target range (0.1–0.5 mIU/L) after the initiation of TKI.

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Outcome results

None listed