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Quality of Life After Interventional Thyroid Treatment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03880578
Acronym
DSR
Enrollment
101
Registered
2019-03-19
Start date
2019-04-01
Completion date
2022-03-15
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid; Deficiency, Quality of Life

Keywords

LT4 treatment, QoL

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.

Interventions

DRUGLevothyroxine Sodium

thyroid hormone replacement

Sponsors

Klinikum Lüdenscheid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)6 monthsquality of life measured by a thyroid specific validated questionnaire

Secondary

MeasureTime frameDescription
Rate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)6 monthsefficiency of converting T4 into T3

Other

MeasureTime frameDescription
Serum Concentration of TSH6 monthsTSH
Serum Concentrations of FT3 and FT46 monthsThyroid hormones FT3, FT4
Thyroid Volume Measured by Ultrasound (ml)6 monthsthyroid capacity

Countries

Germany

Participant flow

Participants by arm

ArmCount
Control
euthyroid patients presenting at fixed intervals for surveillance of non-toxic nodular goitre
50
Radioiodine
Untreated patients with subclinical hyperthyroidism referred for radioiodine treatment
51
Total101

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath010
Overall StudyWithdrawal by Subject031

Baseline characteristics

CharacteristicRadioiodineControlTotal
Age, Continuous61.6 years
STANDARD_DEVIATION 12.5
49.1 years
STANDARD_DEVIATION 14.1
55.4 years
STANDARD_DEVIATION 14.7
FT35.45 pmol/L
STANDARD_DEVIATION 0.71
5.32 pmol/L
STANDARD_DEVIATION 0.7
5.39 pmol/L
STANDARD_DEVIATION 0.7
FT415.3 pmol/L
STANDARD_DEVIATION 2.29
15.4 pmol/L
STANDARD_DEVIATION 2.02
15.3 pmol/L
STANDARD_DEVIATION 2.15
Race/Ethnicity, Customized
Caucasian
51 Participants50 Participants101 Participants
Region of Enrollment
Germany
51 participants50 participants101 participants
Sex: Female, Male
Female
38 Participants37 Participants75 Participants
Sex: Female, Male
Male
13 Participants13 Participants26 Participants
Thyroid volume29.7 ml
STANDARD_DEVIATION 14.2
19.8 ml
STANDARD_DEVIATION 10.3
24.7 ml
STANDARD_DEVIATION 13.3
TSH0.39 mIU/L1.25 mIU/L0.75 mIU/L

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 501 / 51
other
Total, other adverse events
0 / 500 / 51
serious
Total, serious adverse events
0 / 500 / 51

Outcome results

Primary

ThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)

quality of life measured by a thyroid specific validated questionnaire

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
ControlThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)18.3 scoreStandard Deviation 10.8
RadioiodineThyPRO Scale Scores (0-100, Higher Scores Indicating Worse Quality of Life)19.9 scoreStandard Deviation 14.8
p-value: <0.00195% CI: [-14.9, -5.7]Mixed Models Analysis
Secondary

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

efficiency of converting T4 into T3

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
ControlRate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)32.9 nmol/sStandard Deviation 5.03
RadioiodineRate of Global Deiodinase Activity (SPINA-GD, See Reference Calculated Parameters)32.2 nmol/sStandard Deviation 5.52
p-value: 0.0695% CI: [-4.34, 0.06]Mixed Models Analysis
Other Pre-specified

Serum Concentration of TSH

TSH

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
ControlSerum Concentration of TSH1.39 mIU/LStandard Deviation 0.63
RadioiodineSerum Concentration of TSH2.34 mIU/LStandard Deviation 2.58
p-value: <0.00195% CI: [1.27, 2.03]Mixed Models Analysis
Other Pre-specified

Serum Concentrations of FT3 and FT4

Thyroid hormones FT3, FT4

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
ControlSerum Concentrations of FT3 and FT4FT35.33 pmol/LStandard Deviation 0.6
ControlSerum Concentrations of FT3 and FT4FT415.2 pmol/LStandard Deviation 2.13
RadioiodineSerum Concentrations of FT3 and FT4FT34.84 pmol/LStandard Deviation 0.65
RadioiodineSerum Concentrations of FT3 and FT4FT414.2 pmol/LStandard Deviation 2.38
Comparison: FT3p-value: <0.00195% CI: [-0.87, -0.35]Mixed Models Analysis
Comparison: FT4p-value: 0.1295% CI: [-1.81, 0.15]Mixed Models Analysis
Other Pre-specified

Thyroid Volume Measured by Ultrasound (ml)

thyroid capacity

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
ControlThyroid Volume Measured by Ultrasound (ml)20.5 mlStandard Deviation 12.8
RadioiodineThyroid Volume Measured by Ultrasound (ml)18.8 mlStandard Deviation 10.3
p-value: <0.00195% CI: [-14.6, -8.5]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026