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

NCT ID: NCT01840332

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thyroid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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L-thyroxin

this is one arm study

Group Type EXPERIMENTAL

L-thyroxin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tartu

OTHER

Sponsor Role lead

Responsible Party

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Vallo Volke

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vallo Volke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Locations

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East Tallinn Central Hospital

Tallinn, , Estonia

Site Status

Tartu University Hospital

Tartu, , Estonia

Site Status

Countries

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Estonia

Other Identifiers

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1.0 /29.08.2012

Identifier Type: -

Identifier Source: org_study_id

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