Evaluation Study of L-T3 Utility in the Follow-Up of Patients With Thyroid Cancer
Recruitment status was Recruiting
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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 |
- Evaluation of the hypothyroid status by the Billewicz questionnaire.
- The time to reach an acceptable TSH elevation.
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | May 2005 |
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 |
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| Contact: Marie-France Langlois, MD | 819-346-1110 ext 15223 | Marie-France.Langlois@USherbrooke.ca |
| 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 | |
| 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