Influence of Radioiodine Treatment on Thyroid Function and Quality of Life of Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)
研究概览
简要总结
In this study, patients are prospectively followed after radioiodine treatment to assess the relationship between thyroid status and their quality of life after thyroid ablative treatment.
A third treatment arm after surgery has been stopped, as deemed currently not feasible to achieve its target.
详细描述
Patients are frequently dissatisfied with LT4 replacement treatment. The reasons for persisting patient complaints are poorly understood. Conversion efficiency and impaired T3/T4 ratios in athyreotic patients may play a major role. We hypothesised that the extent of ablation either by surgery or radioiodine treatment may result in biochemical disequilibria between FT3, FT4 and TSH and those may be, in turn, associated with persisting symptomatology.
The study follows patients after radioiodine therapy as well as a control group over half a year, assessing thyroid status, set points, conversion rates, thyroid volume, LT4 administration and dosing, demographic characteristics and quality of life measures. The treatment mode is not part of the study, and determined by criteria and procedures of best standard care. For that reason, a randomised or blinded design is not possible.
Changes and interrelationships between thyroid parameters and QoL measures are analysed within-subjects and between treatment groups.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of a thyroid disease requiring radioiodine treatment
- •Clinical diagnosis of a thyroid disease requiring follow-up but no ablative treatment (controls)
- •Clinical diagnosis of a thyroid disease requiring surgery stopped recruiting
排除标准
- •paediatric patients
- •interfering comorbidity
- •non-thyroidal illness
- •pregnancy
- •psychiatric disease
- •severe psychological disorder
- •lack of consent
研究组 & 干预措施
surgery (withdrawn, not continuing recruiting)
thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
干预措施: Levothyroxine Sodium (Drug)
radioiodine
thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment
干预措施: Levothyroxine Sodium (Drug)
control
thyroid patients followed without surgery or radioiodine treatment
干预措施: Levothyroxine Sodium (Drug)
结局指标
主要结局
ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)
时间窗: 6 months
quality of life measured by a thyroid specific validated questionnaire
次要结局
- Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)(6 months)