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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Universitaire de Sherbrooke.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Theramed co.
Information provided by:
Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00223158
First received: September 19, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial

Resource links provided by NLM:


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 Universitaire de Sherbrooke
Principal Investigator: Marie-France Langlois, MD Universitaire de Sherbrooke
Principal Investigator: Patrice Perron, MD Universitaire de Sherbrooke
Principal Investigator: André Carpentier, MD Universitaire de Sherbrooke
Principal Investigator: Jean Verreault, MD Universitaire de Sherbrooke
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00223158     History of Changes
Other Study ID Numbers: CRC 03-52-R1
Study First Received: September 19, 2005
Last Updated: September 19, 2005
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013