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Набор скоро начнётся NCT06647602

Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy

— Наблюдательное Differentiated Thyroid Cancer Thyroid Cancer Levothyroxine Liothyronine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Euthyrox (levothyroxine), Cytomel (liothyronine).
Кому может быть актуально
Состояния в реестре: Differentiated Thyroid Cancer, Thyroid Cancer, Levothyroxine, Liothyronine. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
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Обзор

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

Подробное описание

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

Вмешательства

  • Препарат 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.
  • Препарат 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 2 центра
  • University Medical Center Groningen (UMCG) — Groningen
  • Radboud University Nijmegen — Nijmegen

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗