Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

Study Overview
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Brief Summary
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The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.

Detailed Description
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The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation for the measurement of thyreoglobulin and/or total body scanning. There are two principal methods to obtain TSH elevation: 1) injection of recombinant human TSH , and 2) to stop L-thyroxin replacement for several (3-4) weeks. As use of recombinant TSH is rather expensive, this method is not feasible in many countries. The problem with stopping L-thyroxin is development of severe hypothyroidism for several weeks with concomitant symptoms and signs. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients with fixed dose of L-thyroxin. Concomitantly, blood tests and symptoms and signs of hypothyroidism will be obtained to get information about possible deviations during treatment with low dose of thyroxin.

Official Title
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Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Drug: L-thyroxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Differentiated thyroid cancer treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago TSH < 4 imU/L Exclusion Criteria: Pregnancy Known metastasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-thyroxin<br>this is one arm study | Drug: L-thyroxin<br>* Low dose of L-thyroxin (50 microg/day) will be used during 4 weeks. If TSH is < 30 after 4 weeks the study continues up to 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSH level at the end of study | The percentage of patients obtaining TSH level at least 30 imU/L at the end of study period. Blood tests will be obtained after 4 weeks. If TSH > 30 the patient has completed the study. If TSH < 30 patient will continue for 1 week and blood tests will be obtained after week 5. If TSH > 30 the patient has completed the study. If TSH < 30 patient will be monitored during 1 week and blood tests will be obtained after 6 weeks. | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Billewitz index during the study | Billewitz index measures the severity of hypothyroidism symptoms. Billewitz index will be recorded after 4 weeks and after 5 and 6 weeks if patient continues after 4 or 5 weeks (see primary endpoint for details). | 4-6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer