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Not yet recruiting NCT06647602

Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy

— Observational Differentiated Thyroid Cancer Thyroid Cancer Levothyroxine Liothyronine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Euthyrox (levothyroxine), Cytomel (liothyronine).
Who it may be relevant to
Registry conditions: Differentiated Thyroid Cancer, Thyroid Cancer, Levothyroxine, Liothyronine. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study will be a multicentre prospective cohort study on TH-substitution after thyroid hormone withdrawal preceding radioiodine treatment.

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 addition in initiation of TH treatment 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-T4+L-T3 combination treatment can have a more direct effect on TSH-levels and earlier relieve of hypothyroid symptoms resulting in a better QoL. We will conduct a prospective cohort study comparing the initiation of TH-supplementation after TH-withdrawal in two cohorts of DTC patients: patients receiving L-T4+LT3 with a gradually decrease of L-T3 dose in time, and patients receiving L-T4 only. 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 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-T4+L-T3 or L-T4 in the first 3 months of treatment on serum thyroid parameters TSH and Tg, quality of life, and cardiovascular parameters

Interventions

  • Drug Euthyrox (levothyroxine)
    Euthyrox (levothyroxine sodium tablets; L-T4) is a thyromimetic synthetic drug identical to T4. Patients will recieve levothyroxine (euthyrox) in a dose of 2 μg × kg body weight / day.
  • Drug Cytomel (liothyronine)
    Cytomel (liothyronine sodium tablets; L-T3) is a thyromimetic synthetic drug identical to T3. The patients in this cohort recieve L-T4+L-T3 combination therapy. The L-T4 dose will be 2 μg × kg body weight / day, equal to the dose in the other interventional arm. L-T3 will be added twice daily from the first day of combination treatment, in dosages gradually decreasing from 25 ug 2/day to 5 ug 2/day over a time span of 3 weeks after which L-T3 is stopped.

Primary outcome measures

  • TSH after two weeks of TH substitution [Time frame: Before and after 2 weeks of TH-substitution]
Secondary outcome measures (5)
  • TSH (mU/L) [Time frame: Before and after 1, 2, 4, 6, and 12 weeks of TH-substitution.]
  • Thyroglobulin (Tg; ng/mL) [Time frame: Before and after 1, 2, 4, 6, and 12 weeks of TH-substitution]
  • QoL in patients treated with L-T3 or L-T4 [Time frame: Before and after 2, 6, and 12 weeks of TH-substitution]
  • Heart rate (HR; bpm) [Time frame: Before and after 6 and 12 weeks of TH-substitution]
  • Blood pressure (BP; mmHg) [Time frame: Before and after 6 and 12 weeks of TH-substitution]

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 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 must be fit to adhere to the study protocol
  • Patients must be able to read and understand the Dutch language

Exclusion criteria

  • Pregnancy
  • 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 gastritis
  • Patients using proton-pomp inhibitors

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 2 centers
  • University Medical Center Groningen (UMCG) — Groningen
  • Radboud University Nijmegen — Nijmegen

Identifiers

NCT: NCT06647602 · 11432 · 2024-511668-10-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗