- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223158
Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Evaluation of the hypothyroid status by the Billewicz questionnaire.
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Secondary Outcome Measures
Outcome Measure |
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The time to reach an acceptable TSH elevation.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rébecca Leboeuf, MD, Universite de Sherbrooke
- Principal Investigator: Marie-France Langlois, MD, Universite de Sherbrooke
- Principal Investigator: Patrice Perron, MD, Universite de Sherbrooke
- Principal Investigator: Jean Verreault, MD, Universite de Sherbrooke
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC 03-52-R1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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