Trial | NCT00223158  Report issue

Title

Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    70
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.
Study Started
Sep 30
2003
Primary Completion
May 31
2005
Study Completion
May 31
2005
Last Update
Apr 09
2014
Estimate

Drug Liothyronine

Criteria 

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
No Results Posted