Clinical trial NCT00223158: Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
Official title: L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Cancer
Keywords: Thyroid cancer
Hypothyroidism
Whole Body Scintigraphy
Liothyronine
TSH elevation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Theramed co.
First posted: 2005-09-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evaluation of the hypothyroid status by the Billewicz questionnaire.
Secondary outcomes:
measure: The time to reach an acceptable TSH elevation.
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Rébecca Leboeuf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Marie-France Langlois, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Patrice Perron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: André Carpentier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Jean Verreault, MD
role: PRINCIPAL_INVESTIGATOR
References: