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NCT Number: NCT01840332

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

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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Tallinn Central Hospital, Tallinn, Estonia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-thyroxin

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2013
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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