Thyroid Cancer
Conditions
Keywords
Thyroid cancer, Hypothyroidism, Whole Body Scintigraphy, Liothyronine, TSH elevation
Brief summary
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
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the hypothyroid status by the Billewicz questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| The time to reach an acceptable TSH elevation. | — |
Countries
Canada