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

Information source: Université de Sherbrooke
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Cancer

Intervention: Liothyronine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Patrice Perron

Official(s) and/or principal investigator(s):
Rébecca Leboeuf, MD, Principal Investigator, Affiliation: Université de Sherbrooke
Marie-France Langlois, MD, Principal Investigator, Affiliation: Université de Sherbrooke
Patrice Perron, MD, Principal Investigator, Affiliation: Université de Sherbrooke
André Carpentier, MD, Principal Investigator, Affiliation: Université de Sherbrooke
Jean Verreault, MD, Principal Investigator, Affiliation: Université de Sherbrooke

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.

Clinical Details

Official title: L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Evaluation of the hypothyroid status by the Billewicz questionnaire.

Secondary outcome: The time to reach an acceptable TSH elevation.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec J1H 5N4, Canada
Additional Information

Starting date: September 2003
Last updated: April 8, 2014

Page last updated: August 23, 2015

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