Quality of Life After Interventional Thyroid Treatment

Completed

• Conditions: Quality of Life; Thyroid; Deficiency
• Interventions: Drug: Levothyroxine Sodium

• 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.

Study Timeline

• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-19
• Study Start: 2019-04-01
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2024-01
• Results First Submitted: 2024-01-09
• Results First Submitted QC: 2024-10-26
• Last Update Submitted: 2024-10-26
• Results First Posted: 2024-10-29
• Last Update Posted: 2024-10-29

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

Group	Intervention	Description
surgery (withdrawn, not continuing recruiting)	Levothyroxine Sodium	thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
control	Levothyroxine Sodium	thyroid patients followed without surgery or radioiodine treatment
radioiodine	Levothyroxine Sodium	thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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