An interventional study of Liothyronine in Thyroid Cancer, sponsored by Patrice Perron. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-09.
Sponsored by Patrice Perron · Not applicable, Interventional, and Treatment
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.
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.
802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's planned enrollment of 70 is above the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →This is the only study on the registry with Patrice Perron as lead sponsor.
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Exclusion Criteria:
Evaluation of the hypothyroid status by the Billewicz questionnaire.
The time to reach an acceptable TSH elevation.
This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.
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