Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT06647602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-18
First Post:
2024-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thyroid Hormone for Thyroid Cancer
Sponsor:
University Medical Center Groningen
Organization:
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:
False
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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: