Thyroid; DeficiencyDSRNCT03880578
Quality of Life After Interventional Thyroid Treatment
An observational study of Thyroid; Deficiency and Quality of Life, run by Klinikum Lüdenscheid at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid; Deficiency, Quality of Life
- What is being tested?
- Levothyroxine Sodium
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 15 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: thyroid patients in a routine ambulatory setting specialising in Nuclear Medicine
Who may be able to join
- 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
Who cannot join
- paediatric patients
- interfering comorbidity
- non-thyroidal illness
- pregnancy
- psychiatric disease
- severe psychological disorder
- lack of consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Nuclear Medicine Klinikum Luedenscheid
Lüdenscheid, North Rhine-Westphalia, 58515
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid; Deficiency, Quality of Life
- Being tested
- Levothyroxine Sodium
- Keywords
- LT4 treatment, QoL
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine SodiumDrug
Also called LT4
thyroid hormone replacement
| Study group | Role | What they receive |
|---|---|---|
| surgery (withdrawn, not continuing recruiting) | thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy Receives: Drug: Levothyroxine Sodium | |
| radioiodine | thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment Receives: Drug: Levothyroxine Sodium | |
| control | thyroid patients followed without surgery or radioiodine treatment Receives: Drug: Levothyroxine Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)
quality of life measured by a thyroid specific validated questionnaire
Measured: 6 months
Secondary outcomes (1)
Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)
efficiency of converting T4 into T3
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Apr 2019
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Thyroid; DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Lüdenscheid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolf Larisch, Professor, Principal investigator, Director of DepartmentRudolf Hoermann, Professor, Study chair, Klinikum Lüdenscheid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880578
- Sponsor's protocol ID
- 2019-01-30/R3
- Other IDs
- 2019-01-30/R3
- Acronym
- DSR
- Status last verified
- Jan 2024
- First submitted
- 14 Mar 2019
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data are principally shared depending on compliance with relevant regulations and authorisation
Publications
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.
PubMed 29396968Hoermann 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.
PubMed 29375474Hoermann 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.
PubMed 30022470Hoermann 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.
PubMed 26635726Hoermann 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.
PubMed 29155897Midgley 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.
PubMed 26335522Hoermann 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.
PubMed 23184912Winther 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.
PubMed 27257805Dietrich 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.
PubMed 27375554
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Radioiodine Treatment on Thyroid Function and Quality of Life of Patients
- ClinicalTrials.gov ID
- NCT03880578
- Acronym / sponsor ID
- DSR / 2019-01-30/R3
- Conditions
- Thyroid; Deficiency, Quality of Life
- Keywords
- LT4 treatment, QoL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Klinikum LüdenscheidUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| surgery (withdrawn, not continuing recruiting) | – | Drug: Levothyroxine Sodiumthyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy |
| radioiodine | – | Drug: Levothyroxine Sodiumthyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment |
| control | – | Drug: Levothyroxine Sodiumthyroid patients followed without surgery or radioiodine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- thyroid patients in a routine ambulatory setting specialising in Nuclear Medicine
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- paediatric patients
- interfering comorbidity
- non-thyroidal illness
- pregnancy
- psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levothyroxine SodiumAlso: LT4thyroid hormone replacement | Drug | control, radioiodine, surgery (withdrawn, not continuing recruiting) |
Primary outcome
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
1 secondary outcome
Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29396968Larisch 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.
- Background: PubMed 29375474Hoermann 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.
- Background: PubMed 30022470Hoermann 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.
- Background: PubMed 26635726Hoermann 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.
- Background: PubMed 29155897Hoermann 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.
- Background: PubMed 26335522Midgley 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.
- Background: PubMed 23184912Hoermann 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.
- Background: PubMed 27257805Winther 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.
- Background: PubMed 27375554Dietrich 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.
- Individual participant dataSharing planned: Undecided. Data are principally shared depending on compliance with relevant regulations and authorisation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Larisch, Professor principal investigator
Director of Department
Rudolf Hoermann, Professor study chair
Klinikum Lüdenscheid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid; Deficiency and Quality of Life, run by Klinikum Lüdenscheid at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880578, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.