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

Not Applicable

Completed

• Conditions: Thyroid Cancer

• Registration Number: NCT00223158
• Lead Sponsor: Patrice Perron

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.

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Status Verified: 2005-07
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients with well-differentiated thyroid cancer, with total thyroidectomy
• 18 y.o. or older

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of the hypothyroid status by the Billewicz questionnaire.

Secondary Outcome Measures

Name	Time	Method
The time to reach an acceptable TSH elevation.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada