Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT00223158|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer||Drug: Liothyronine||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
- Evaluation of the hypothyroid status by the Billewicz questionnaire.
- The time to reach an acceptable TSH elevation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223158
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|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|