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
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer||Drug: L-thyroxin||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
this is one arm study
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.
- 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.
- 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).
- 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).
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
|East Tallinn Central Hospital|
|Tallinn, Estonia, 10138|
|Tartu University Hospital|
|Tartu, Estonia, 50406|
|Principal Investigator:||Vallo Volke, MD, PhD||Tartu University|