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

March 13, 2014 updated by: Vallo Volke, University of Tartu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital
      • Tartu, Estonia, 50406
        • Tartu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-thyroxin
this is one arm study
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TSH level at the end of study
Time Frame: 4-6 weeks

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Billewitz index during the study
Time Frame: 4-6 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in biochemical parameters during the study
Time Frame: 4-6 weeks
Change in parameters related to hypothyroidism (thyroid hormones, creatinine kinase, cholesterol,ultra sensitive CRP, creatinine).
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Investigators

  • Principal Investigator: Vallo Volke, MD, PhD, Tartu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0 /29.08.2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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