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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01840332
Other study ID # 1.0 /29.08.2012
Secondary ID
Status Completed
Phase N/A
First received April 22, 2013
Last updated March 13, 2014
Start date April 2013
Est. completion date February 2014

Study information

Verified date March 2014
Source University of Tartu
Contact n/a
Is FDA regulated No
Health authority Estonia: The State Agency of Medicine
Study type Interventional

Clinical Trial Summary

The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.


Description:

The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation for the measurement of thyreoglobulin and/or total body scanning. There are two principal methods to obtain TSH elevation: 1) injection of recombinant human TSH , and 2) to stop L-thyroxin replacement for several (3-4) weeks. As use of recombinant TSH is rather expensive, this method is not feasible in many countries. The problem with stopping L-thyroxin is development of severe hypothyroidism for several weeks with concomitant symptoms and signs.

Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients with fixed dose of L-thyroxin. Concomitantly, blood tests and symptoms and signs of hypothyroidism will be obtained to get information about possible deviations during treatment with low dose of thyroxin.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Differentiated thyroid cancer

- treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago

- TSH < 4 imU/L

Exclusion Criteria:

- Pregnancy

- Known metastasis

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
L-thyroxin
Low dose of L-thyroxin (50 microg/day) will be used during 4 weeks. If TSH is < 30 after 4 weeks the study continues up to 6 weeks.

Locations

Country Name City State
Estonia East Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu

Sponsors (1)

Lead Sponsor Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type Measure Description Time frame Safety issue
Other change in biochemical parameters during the study Change in parameters related to hypothyroidism (thyroid hormones, creatinine kinase, cholesterol,ultra sensitive CRP, creatinine). 4-6 weeks No
Primary TSH level at the end of study The percentage of patients obtaining TSH level at least 30 imU/L at the end of study period.
Blood tests will be obtained after 4 weeks. If TSH > 30 the patient has completed the study. If TSH < 30 patient will continue for 1 week and blood tests will be obtained after week 5. If TSH > 30 the patient has completed the study. If TSH < 30 patient will be monitored during 1 week and blood tests will be obtained after 6 weeks.
4-6 weeks No
Secondary change in Billewitz index during the study Billewitz index measures the severity of hypothyroidism symptoms. Billewitz index will be recorded after 4 weeks and after 5 and 6 weeks if patient continues after 4 or 5 weeks (see primary endpoint for details). 4-6 weeks No
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