NCT03880578

Quality of Life After Interventional Thyroid Treatment

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Klinikum Lüdenscheid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid; Deficiency
• Quality of Life

Interventions

Type	Name	Description
DRUG	Levothyroxine Sodium	thyroid hormone replacement

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2019-03-19
• Last updated: 2024-10-29
• Results posted: 2024-10-29

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study