Clinical trial NCT06647602: Thyroid Hormone for Thyroid Cancer
Official title: Comparing Effects of Thyroid Hormone Medication Liothyronine and Levothyroxine in Treatment for Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Differentiated Thyroid Cancer
Thyroid Cancer
Levothyroxine
Liothyronine
Thyroid Hormones
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2024-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include patients with a histologically confirmed high-risk DTC, men and women aged 18-75 years. Patients have to be prepared to RAI with TH-withdrawal and treated according to the ATA guidelines in the UMCG or in the Radboud UMC.

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

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed DTC (papillary thyroid carcinoma, follicular thyroid carcinoma, oncocytic thyroid carcinoma)
* Classified as high-risk DTC according to the ATA guidelines (1) or, patients for whom the risk of a recurrence is estimated to be higher based on clinical features (assessed by their treating physician).
* Prepared for RAI-therapy with TH-withdrawal
* Patients have to be fit to adhere to the study protocol
* Patients have to be able to read and understand the Dutch language

Exclusion Criteria:

* Pregnancy
* Patients with a psychiatric history or history of depression
* Patients with comorbidities, such as severe heart failure, (poorly controlled) atrial fibrillation, of which the treating physician decides that L-T3 is unsuitable.

Conditions or drugs interfering with thyroid hormone uptake:

- Patients with a history of atrophic gastriti

Primary outcomes:
measure: TSH after two weeks of TH substitution
timeFrame: Before and after 2 weeks of TH-substitution
Secondary outcomes:
measure: TSH (mU/L)
timeFrame: Before and after 1, 2, 4, 6, 12 and 24 weeks of TH-substitution
measure: Thyroglobulin (Tg; ng/mL)
timeFrame: Before and after 1, 2, 4, 6, 12 and 24 weeks of TH-substitution
measure: QoL in patients treated with L-T3 or L-T4
timeFrame: Before and after 2, 6, 12 and 24 weeks of TH-substitution
measure: Weight (Kg)
timeFrame: Before and after 6 and 24 weeks of TH-substitution
measure: Body-mass index (BMI; Kg/m2)
timeFrame: Before and after 6 and 24 weeks of TH-substitution
measure: Heart rate (HR; bpm)
timeFrame: Before and after 6 weeks of TH-substitution
measure: Blood pressure (BP; mmHg)
timeFrame: Before and after 6 weeks of TH-substitution
measure: Lipid profile (cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides)
timeFrame: Before and after 6 weeks of TH-substitution
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen
Study officials:
affiliation: UMCG
name: Wouter Zandee, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: