Quality of Life After Interventional Thyroid Treatment (DSR)

Klinikum Lüdenscheid

Status: Completed

Conditions: Quality of Life; Thyroid; Deficiency

Treatments: Drug: Levothyroxine Sodium

Study type: Observational

Funder types: Other

Identifiers

NCT03880578

2019-01-30/R3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

101 participants in 3 patient groups

surgery (withdrawn, not continuing recruiting)

Description:

thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy

Treatment:

Drug: Levothyroxine Sodium

radioiodine

Description:

thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment

Treatment:

Drug: Levothyroxine Sodium

control

Description:

thyroid patients followed without surgery or radioiodine treatment

Treatment:

Drug: Levothyroxine Sodium