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CompletedNCT00223158Updated Apr 9, 2014

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

An interventional study of Liothyronine in Thyroid Cancer, sponsored by Patrice Perron. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-09.

Sponsored by Patrice Perron · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyroid Cancer

Keywords

  • Thyroid cancer
  • Hypothyroidism
  • Whole Body Scintigraphy
  • Liothyronine
  • TSH elevation
03

In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's planned enrollment of 70 is above the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

This is the only study on the registry with Patrice Perron as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with well-differentiated thyroid cancer, with total thyroidectomy
  • 18 y.o. or older

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
70 participants (estimated)

Interventions

  • DrugLiothyronine
06

What researchers measure

Primary outcomes

  1. Evaluation of the hypothyroid status by the Billewicz questionnaire.

Secondary outcomes

  1. The time to reach an acceptable TSH elevation.

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Sherbrooke
    Sherbrooke, Quebec J1H 5N4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00223158
Lead sponsor
Patrice Perron
Collaborators
Theramed co.
Responsible party
Patrice Perron (MD, Université de Sherbrooke) — Sponsor-investigator
First posted
Sep 22, 2005
Start date
Sep 2003
Primary completion
May 2005
Completion
May 2005
Last update
Apr 9, 2014

Study contacts

Rébecca Leboeuf, MD
principal investigator · Université de Sherbrooke
Marie-France Langlois, MD
principal investigator · Université de Sherbrooke
Patrice Perron, MD
principal investigator · Université de Sherbrooke
André Carpentier, MD
principal investigator · Université de Sherbrooke
Jean Verreault, MD
principal investigator · Université de Sherbrooke
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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