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Evaluation Study of L-T3 Utility in the Follow-Up of Patients With Thyroid Cancer

This study is currently recruiting participants.
Verified by Universitaire de Sherbrooke, July 2005

Sponsors and Collaborators: Universitaire de Sherbrooke
Theramed co.
Information provided by: Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00223158
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Evaluation of the hypothyroid status by the Billewicz questionnaire.

Secondary Outcome Measures:
  • The time to reach an acceptable TSH elevation.

Estimated Enrollment:   70
Study Start Date:   September 2003
Estimated Study Completion Date:   May 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223158

Contacts
Contact: Marie-France Langlois, MD     819-346-1110 ext 15223     Marie-France.Langlois@USherbrooke.ca    

Locations
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            

Sponsors and Collaborators
Universitaire de Sherbrooke
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    
  More Information


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

Keywords provided by Universitaire de Sherbrooke:
Thyroid cancer  
Hypothyroidism  
Whole Body Scintigraphy  
Liothyronine  
TSH elevation  

Study placed in the following topic categories:
Thyroid Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Hypothyroidism
Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 03, 2008




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