Quality of Life After Interventional Thyroid Treatment

Quality of Life Clinical Trial

— DSR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880578
• Other study ID #: 2019-01-30/R3
• Secondary ID: 2019-01-30/R3
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Klinikum Lüdenscheid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism
• Quality of Life
• Thyroid Diseases
• Thyroid; Deficiency

Intervention

Drug:
• Levothyroxine Sodium
thyroid hormone replacement

Locations

Country	Name	City	State
Germany	Department of Nuclear Medicine Klinikum Luedenscheid	Luedenscheid	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Lüdenscheid

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum concentrations of TSH, FT4, FT3	biochemical thyroid function tests	6 months
Other	thyroid volume measured by ultrasound (ml)	thyroid capacity	6 months
Primary	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	rate of global deiodinase activity (SPINA-GD, see reference calculated parameters)	efficiency of converting T4 into T3	6 months