Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
Primary Purpose
Thyroid Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Liothyronine
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer focused on measuring Thyroid cancer, Hypothyroidism, Whole Body Scintigraphy, Liothyronine, TSH elevation
Eligibility 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
Sites / Locations
- Centre Hospitalier Universitaire de Sherbrooke
Outcomes
Primary Outcome Measures
Evaluation of the hypothyroid status by the Billewicz questionnaire.
Secondary Outcome Measures
The time to reach an acceptable TSH elevation.
Full Information
NCT ID
NCT00223158
First Posted
September 19, 2005
Last Updated
April 8, 2014
Sponsor
Patrice Perron
Collaborators
Theramed co.
1. Study Identification
Unique Protocol Identification Number
NCT00223158
Brief Title
Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
Official Title
L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrice Perron
Collaborators
Theramed co.
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Thyroid cancer, Hypothyroidism, Whole Body Scintigraphy, Liothyronine, TSH elevation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Liothyronine
Primary Outcome Measure Information:
Title
Evaluation of the hypothyroid status by the Billewicz questionnaire.
Secondary Outcome Measure Information:
Title
The time to reach an acceptable TSH elevation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rébecca Leboeuf, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie-France Langlois, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrice Perron, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
André Carpentier, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Verreault, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer
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