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OpenTrials
Completed

NCT Number: NCT03880578

Quality of Life After Interventional Thyroid Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear Medicine Klinikum Luedenscheid

Lüdenscheid, North Rhine-Westphalia, 58515, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levothyroxine Sodium

Drug

thyroid hormone replacement

Other names: LT4

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)

    Time frame: 6 months

    efficiency of converting T4 into T3

Other outcomes

  1. Serum Concentration of TSH

    Time frame: 6 months

    TSH

  2. Serum Concentrations of FT3 and FT4

    Time frame: 6 months

    Thyroid hormones FT3, FT4

  3. Thyroid Volume Measured by Ultrasound (ml)

    Time frame: 6 months

    thyroid capacity

Sponsors and collaborators

Lead sponsor

Klinikum Lüdenscheid

Other

Registry information

Official study title

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

Acronym: DSR

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2019
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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