Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647602
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-11
Brief Title:
Thyroid Hormone for Thyroid Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing Effects of Thyroid Hormone Medication Liothyronine and Levothyroxine in Treatment for Thyroid Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T4T
Brief Summary:
This study will be a multicentre prospective cohort study on TH-substitution with liothyronine L-T3 and levothyroxine L-T4 in DTC patients after TH-withdrawal The first cohort is patients treated in the University Medical Centre Groningen UMCG with L-T3 according to standard local protocol The second cohort is patients treated in the Radboud University Medical Centre Radboud UMC with L-T4 also according to standard local protocol We will compare effects of L-T3 or L-T4 on TSH Thyroglobulin Tg quality of life QoL weight and cardiovascular parameters
Detailed Description:
While treatment with L-T4 after TH-withdrawal is widely used in DTC patients to suppress TSH and improve hypothyroid symptoms the value of L-T3 has not been evaluated in this context Lifelong monotherapy with L-T3 should not be preferred over L-T4 yet short-term use of L-T3 to initiate TH-supplementation can be safely implemented We hypothesize that initial treatment with L-T3 can have a more rapid effect on TSH-levels and earlier relieve of hypothyroid symptoms resulting in a better QoL To evaluate TH-supplementation with L-T3 we will conduct a prospective cohort study comparing the initiation of TH-supplementation after TH-withdrawal in two cohorts of DTC patients patients treated in the University Medical Centre Groningen UMCG receiving L-T3 and patients treated in the Radboud University Medical Centre Radboud UMC receiving L-T4 We will compare potency to suppress TSH effect on QoL and effects on thyroid- and cardiovascular parameters Patients 18-75 years diagnosed with high-risk DTC treated in the UMCG or Radboud UMC and receiving THST with L-T3 or L-T4 after TH-withdrawal will be eligible for inclusion The primary objective is to compare the proportion of patients reaching target TSH-levels after two weeks of substitution with L-T3 or L-T4
Secondary objectives are to compare the effects of L-T3 and L-T4 in the first 6 months of treatment on serum thyroid parameters TSH and Tg quality of life weight and cardiovascular parameters
Secondary objectives are to compare the effects of L-T3 and L-T4 in the first 6 months of treatment on serum thyroid parameters TSH and Tg quality of life weight and cardiovascular parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None