Quality of Life After Interventional Thyroid Treatment (DSR)
October 26, 2024 updated by: Klinikum Lüdenscheid
Influence of Radioiodine Treatment on Thyroid Function and Quality of Life of Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
101
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Luedenscheid, NRW, Germany, 58515
- Department of Nuclear Medicine Klinikum Luedenscheid
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
thyroid patients in a routine ambulatory setting specialising in Nuclear Medicine
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
surgery (withdrawn, not continuing recruiting)
thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
|
thyroid hormone replacement
Other Names:
|
|
radioiodine
thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment
|
thyroid hormone replacement
Other Names:
|
|
control
thyroid patients followed without surgery or radioiodine treatment
|
thyroid hormone replacement
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
efficiency of converting T4 into T3
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Concentration of TSH
Time Frame: 6 months
|
TSH
|
6 months
|
|
Serum Concentrations of FT3 and FT4
Time Frame: 6 months
|
Thyroid hormones FT3, FT4
|
6 months
|
|
Thyroid Volume Measured by Ultrasound (ml)
Time Frame: 6 months
|
thyroid capacity
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rolf Larisch, Professor, director of department
- Study Chair: Rudolf Hoermann, Professor, Klinikum Lüdenscheid
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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 AK, Hegedus 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
March 15, 2022
Study Completion (Actual)
March 15, 2022
Study Registration Dates
First Submitted
March 14, 2019
First Submitted That Met QC Criteria
March 15, 2019
First Posted (Actual)
March 19, 2019
Study Record Updates
Last Update Posted (Actual)
October 29, 2024
Last Update Submitted That Met QC Criteria
October 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-01-30/R3 (Other Identifier: Klinikum Luedenscheid)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Data are principally shared depending on compliance with relevant regulations and authorisation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.