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

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ClinicalTrials.gov Identifier: NCT01840332
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Vallo Volke, University of Tartu

Brief 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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: L-thyroxin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840332


Locations
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Estonia
East Tallinn Central Hospital
Tallinn, Estonia, 10138
Tartu University Hospital
Tartu, Estonia, 50406
Sponsors and Collaborators
University of Tartu
Investigators
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Principal Investigator: Vallo Volke, MD, PhD Tartu University

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Responsible Party: Vallo Volke, Dr., University of Tartu
ClinicalTrials.gov Identifier: NCT01840332     History of Changes
Other Study ID Numbers: 1.0 /29.08.2012
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014
Keywords provided by Vallo Volke, University of Tartu:
thyroid cancer
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms