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Sponsors and Collaborators: |
Universitaire de Sherbrooke Theramed co. |
Information provided by: | Universitaire de Sherbrooke |
ClinicalTrials.gov Identifier: | NCT00223158 |
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 | Intervention |
Thyroid Cancer |
Drug: Liothyronine |
MedlinePlus related topics: | Cancer Nuclear Scans Thyroid Cancer |
ChemIDplus related topics: | Sodium iodide I 131 Thyroid Triiodothyronine Liothyronine sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial |
Estimated Enrollment: | 70 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | May 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marie-France Langlois, MD | 819-346-1110 ext 15223 | Marie-France.Langlois@USherbrooke.ca |
Canada, Quebec | |||||
Centre Hospitalier Universitaire de Sherbrooke | Recruiting | ||||
Sherbrooke, Quebec, Canada, J1H 5N4 | |||||
Contact: Marie-France Langlois, MD 819-346-1110 ext 15223 Marie-France.Langlois@USherbrooke.ca | |||||
Centre Hospitalier Universitaire de Sherbrooke | Recruiting | ||||
Sherbrooke, Quebec, Canada, J1H 5N4 | |||||
Contact: Marie-France Langlois, MD 819-346-1110 ext 15223 Marie-France.Langloius@USherbrooke.ca | |||||
Principal Investigator: Marie-France Langlois, MD | |||||
Sub-Investigator: Rébecca Leboeuf, MD | |||||
Sub-Investigator: Perron Patrice, MD | |||||
Sub-Investigator: André Carpentier, MD | |||||
Sub-Investigator: Jean Verreault, MD |
Universitaire de Sherbrooke |
Theramed co. |
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 ID Numbers: | CRC 03-52-R1 |
First Received: | September 19, 2005 |
Last Updated: | September 19, 2005 |
ClinicalTrials.gov Identifier: | NCT00223158 |
Health Authority: | Canada: Health Canada |
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