Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223158
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
Theramed co.
Information provided by (Responsible Party):
Patrice Perron, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: Liothyronine Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial
Study Start Date : September 2003
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine





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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223158


Locations
Layout table for location information
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Patrice Perron
Theramed co.
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Patrice Perron, MD, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00223158    
Other Study ID Numbers: CRC 03-52-R1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: July 2005
Keywords provided by Patrice Perron, Université de Sherbrooke:
Thyroid cancer
Hypothyroidism
Whole Body Scintigraphy
Liothyronine
TSH elevation
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms