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

This study has been completed.
Sponsor:
Collaborator:
Theramed co.
Information provided by (Responsible Party):
Patrice Perron, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00223158
First received: September 19, 2005
Last updated: April 8, 2014
Last verified: July 2005

September 19, 2005
April 8, 2014
September 2003
May 2005   (final data collection date for primary outcome measure)
Evaluation of the hypothyroid status by the Billewicz questionnaire.
Same as current
Complete list of historical versions of study NCT00223158 on ClinicalTrials.gov Archive Site
The time to reach an acceptable TSH elevation.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Thyroid Cancer
Drug: Liothyronine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
May 2005
May 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00223158
CRC 03-52-R1
Not Provided
Patrice Perron, Université de Sherbrooke
Patrice Perron
Theramed co.
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
Université de Sherbrooke
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP