Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer

Study Overview
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Brief Summary
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To compare the hypothyroid state in patients with thyroid cancer prepared either by placebo or L-T3 following L-T4 withdrawal in preparation for whole body scintigraphy. To evaluate the time needed for TSH elevation (> 30 mUI/L) on placebo vs. L-T3.

Detailed Description
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Patients with well differentiated thyroid cancer (DTC) need whole-body scintigraphy (WBS) and thyroglobulin (Tg) measurement in order to detect recurrence. Classically, withdrawal from levothyroxine (L-T4) during 4-6 weeks is needed for TSH elevation (> 30mUI/L), to allow iodine uptake and Tg production. As a result, patients become hypothyroid with impaired quality of life and a potential for tumour flare-up. Recombinant hTSH before WBS prevents hypothyroidism but is not yet approved for radioiodine treatment and is an expensive therapy. L-T3 substitution during the first 2-3 weeks of withdrawal is an alternative used empirically to prepare patients; however, no data exists to prove its benefit upon reducing hypothyroidism. Objectives: 1) To compare the hypothyroid state in patients prepared either by placebo or L-T3 following L-T4 withdrawal. 2) To evaluate the time needed for TSH elevation (> 30 mUI/L) on placebo vs. L-T3. Method: At the time of L-T4 withdrawal or after thyroidectomy, patients with DTC awaiting WBS or radioiodine treatment were randomized in two groups (double-blind): L-T3 (50 mg qd) or an identical placebo for 3 weeks, after which treatment was stopped for 2 weeks. A validated questionnaire of signs and symptoms of hypothyroidism (Billewicz's scale) was administered every 2 weeks until the WBS. TSH, fT4 and fT3 were measured weekly.

Official Title
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L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Drug: Liothyronine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with well-differentiated thyroid cancer, with total thyroidectomy 18 y.o. or older Exclusion Criteria: Use of rhTSH for Whole Body Scintigraphy preparation Non stable cardiac arrythmias Any condition impairing TSH elevation(glucocorticoid use, hypopituitarism) Allergy to Liothyronine Inability to give a consent

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Liothyronine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the hypothyroid status by the Billewicz questionnaire. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to reach an acceptable TSH elevation. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid cancer, Hypothyroidism, Whole Body Scintigraphy, Liothyronine, TSH elevation