Quality of Life After Interventional Thyroid Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Radioiodine Treatment on Thyroid Function and Quality of Life of Patients

Conditions
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Thyroid; Deficiency, Quality of Life

Intervention / Treatment
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* Drug: Levothyroxine Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: paediatric patients interfering comorbidity non-thyroidal illness pregnancy psychiatric disease severe psychological disorder lack of consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgery (withdrawn, not continuing recruiting)<br>thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy | Drug: Levothyroxine Sodium<br>* thyroid hormone replacement<br>* Other names: LT4;|
| radioiodine<br>thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment | Drug: Levothyroxine Sodium<br>* thyroid hormone replacement<br>* Other names: LT4;|
| control<br>thyroid patients followed without surgery or radioiodine treatment | Drug: Levothyroxine Sodium<br>* thyroid hormone replacement<br>* Other names: LT4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ThyPRO scale scores (0-100, higher scores indicating worse quality of life) | quality of life measured by a thyroid specific validated questionnaire | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of global deiodinase activity (SPINA-GD, see reference calculated parameters) | efficiency of converting T4 into T3 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QoL, LT4 treatment