DSR: Quality of Life After Interventional Thyroid Treatment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| surgery (withdrawn, not continuing recruiting) thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy |
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Names:
|
| radioiodine thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment |
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Names:
|
| control thyroid patients followed without surgery or radioiodine treatment |
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Names:
|
Outcome Measures
Primary Outcome Measures
- ThyPRO scale scores (0-100, higher scores indicating worse quality of life) [6 months]
quality of life measured by a thyroid specific validated questionnaire
Secondary Outcome Measures
- rate of global deiodinase activity (SPINA-GD, see reference calculated parameters) [6 months]
efficiency of converting T4 into T3
Other Outcome Measures
- serum concentrations of TSH, FT4, FT3 [6 months]
biochemical thyroid function tests
- thyroid volume measured by ultrasound (ml) [6 months]
thyroid capacity
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Nuclear Medicine Klinikum Luedenscheid | Luedenscheid | NRW | Germany | 58515 |
Sponsors and Collaborators
- Klinikum Lüdenscheid
Investigators
- Principal Investigator: Rolf Larisch, Professor, Director of Department
- Study Chair: Rudolf Hoermann, Professor, Klinikum Lüdenscheid
Study Documents (Full-Text)
None provided.More Information
Publications
- Dietrich JW, Landgrafe-Mende G, Wiora E, Chatzitomaris A, Klein HH, Midgley JE, Hoermann R. Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Front Endocrinol (Lausanne). 2016 Jun 9;7:57. doi: 10.3389/fendo.2016.00057. eCollection 2016.
- Hoermann R, Midgley JE, Larisch R, Dietrich JW. Homeostatic Control of the Thyroid-Pituitary Axis: Perspectives for Diagnosis and Treatment. Front Endocrinol (Lausanne). 2015 Nov 20;6:177. doi: 10.3389/fendo.2015.00177. eCollection 2015. Review.
- Hoermann R, Midgley JE, Larisch R, Dietrich JW. Is pituitary TSH an adequate measure of thyroid hormone-controlled homoeostasis during thyroxine treatment? Eur J Endocrinol. 2013 Jan 17;168(2):271-80. doi: 10.1530/EJE-12-0819. Print 2013 Feb.
- Hoermann R, Midgley JEM, Larisch R, Dietrich JW. Recent Advances in Thyroid Hormone Regulation: Toward a New Paradigm for Optimal Diagnosis and Treatment. Front Endocrinol (Lausanne). 2017 Dec 22;8:364. doi: 10.3389/fendo.2017.00364. eCollection 2017. Review.
- Hoermann R, Midgley JEM, Larisch R, Dietrich JW. The role of functional thyroid capacity in pituitary thyroid feedback regulation. Eur J Clin Invest. 2018 Oct;48(10):e13003. doi: 10.1111/eci.13003. Epub 2018 Aug 1.
- Hoermann R, Midgley JEM, Larisch R, Dietrich JWC. Advances in applied homeostatic modelling of the relationship between thyrotropin and free thyroxine. PLoS One. 2017 Nov 20;12(11):e0187232. doi: 10.1371/journal.pone.0187232. eCollection 2017.
- Larisch R, Midgley JEM, Dietrich JW, Hoermann R. Symptomatic Relief is Related to Serum Free Triiodothyronine Concentrations during Follow-up in Levothyroxine-Treated Patients with Differentiated Thyroid Cancer. Exp Clin Endocrinol Diabetes. 2018 Sep;126(9):546-552. doi: 10.1055/s-0043-125064. Epub 2018 Feb 2.
- Midgley JE, Larisch R, Dietrich JW, Hoermann R. Variation in the biochemical response to l-thyroxine therapy and relationship with peripheral thyroid hormone conversion efficiency. Endocr Connect. 2015 Dec;4(4):196-205. doi: 10.1530/EC-150056.
- Winther KH, Cramon P, Watt T, Bjorner JB, Ekholm O, Feldt-Rasmussen U, Groenvold M, Rasmussen ÅK, Hegedüs L, Bonnema SJ. Disease-Specific as Well as Generic Quality of Life Is Widely Impacted in Autoimmune Hypothyroidism and Improves during the First Six Months of Levothyroxine Therapy. PLoS One. 2016 Jun 3;11(6):e0156925. doi: 10.1371/journal.pone.0156925. eCollection 2016.
- 2019-01-30/R3
- 2019-01-30/R3