Quality of Life After Interventional Thyroid Treatment (DSR)

March 28, 2022 updated by: Klinikum Lüdenscheid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Luedenscheid, NRW, Germany, 58515
        • Department of Nuclear Medicine Klinikum Luedenscheid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

thyroid patients in a routine ambulatory setting specialising in Nuclear Medicine

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
surgery (withdrawn, not continuing recruiting)
thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Names:
  • LT4
radioiodine
thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Names:
  • LT4
control
thyroid patients followed without surgery or radioiodine treatment
Drug: Levothyroxine Sodium
thyroid hormone replacement
Other Names:
  • LT4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of global deiodinase activity (SPINA-GD, see reference calculated parameters)
Time Frame: 6 months
efficiency of converting T4 into T3
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum concentrations of TSH, FT4, FT3
Time Frame: 6 months
biochemical thyroid function tests
6 months
thyroid volume measured by ultrasound (ml)
Time Frame: 6 months
thyroid capacity
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Lüdenscheid

Investigators

  • Principal Investigator: Rolf Larisch, Professor, director of department
  • Study Chair: Rudolf Hoermann, Professor, Klinikum Lüdenscheid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

March 15, 2022

Study Completion (ACTUAL)

March 15, 2022

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (ACTUAL)

March 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01-30/R3 (OTHER: Klinikum Luedenscheid)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data are principally shared depending on compliance with relevant regulations and authorisation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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