Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- TSH after two weeks of TH substitution
研究概览
简要总结
This study will be a multicentre prospective cohort study on TH-substitution after thyroid hormone withdrawal preceding radioiodine treatment.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Levothyroxine cohort
L-T4 monotherapy according to local protocol.
干预措施: Euthyrox (levothyroxine) (Drug)
TH-combination cohort
L-T4+L-T3 combination according to local protocol.
干预措施: Cytomel (liothyronine) (Drug)
结局指标
主要结局
TSH after two weeks of TH substitution
时间窗: Before and after 2 weeks of TH-substitution
The percentage of patients reaching target TSH (\<0.5 mU/L) after two weeks of L-T3+L-T4 substitution compared to patients with L-T4-substitution.
次要结局
- TSH (mU/L)(Before and after 1, 2, 4, 6, and 12 weeks of TH-substitution.)
- Thyroglobulin (Tg; ng/mL)(Before and after 1, 2, 4, 6, and 12 weeks of TH-substitution)
- QoL in patients treated with L-T3 or L-T4(Before and after 2, 6, and 12 weeks of TH-substitution)
- Heart rate (HR; bpm)(Before and after 6 and 12 weeks of TH-substitution)
- Blood pressure (BP; mmHg)(Before and after 6 and 12 weeks of TH-substitution)