MedPath

Quality of Life After Interventional Thyroid Treatment

Completed
Conditions
Quality of Life
Thyroid; Deficiency
Interventions
Registration Number
NCT03880578
Lead Sponsor
Klinikum Lüdenscheid
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
101
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
surgery (withdrawn, not continuing recruiting)Levothyroxine Sodiumthyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
controlLevothyroxine Sodiumthyroid patients followed without surgery or radioiodine treatment
radioiodineLevothyroxine Sodiumthyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)6 months

efficiency of converting T4 into T3

Trial Locations

Locations (1)

Department of Nuclear Medicine Klinikum Luedenscheid

🇩🇪

Luedenscheid, NRW, Germany

Department of Nuclear Medicine Klinikum Luedenscheid
🇩🇪Luedenscheid, NRW, Germany

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