Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840332
• Other study ID #: 1.0 /29.08.2012
• 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

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

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