Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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 Design
Outcome Measures
Primary Outcome Measures
- Evaluation of the hypothyroid status by the Billewicz questionnaire. []
Secondary Outcome Measures
- The time to reach an acceptable TSH elevation. []
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada | J1H 5N4 |
Sponsors and Collaborators
- Patrice Perron
- Theramed co.
Investigators
- Principal Investigator: Rébecca Leboeuf, MD, Université de Sherbrooke
- Principal Investigator: Marie-France Langlois, MD, Université de Sherbrooke
- Principal Investigator: Patrice Perron, MD, Université de Sherbrooke
- Principal Investigator: André Carpentier, MD, Université de Sherbrooke
- Principal Investigator: Jean Verreault, MD, Université de Sherbrooke
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRC 03-52-R1