Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
NCT ID: NCT00604318
Last Updated: 2013-01-10
Study Results
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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COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2008-02-29
2012-02-29
Brief Summary
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Detailed Description
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The patients will be randomised to either T3 pause related to the first radioiodine treatment and Thyrogen injection (recombinant TSH) related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.
All medication given in the 10 days period right before radioiodine treatment/uptake will be delivered to the patients and marked with a protocol number. In the period with T3 pause the patients will be given placebo tablets and an injection of saline (instead of Thyrogen) before treatment/uptake at the similar time as given the Thyrogen injection. A nurse otherwise not involved in the study will give the injection.
Patients will be evaluated by VAS, SF-36, and Eortc QLC30 (version 2.0) before radioiodine treatment and 3 weeks after treatment.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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placebo
To receive the placebo treatment in connection with the primary RI therapy and the T3 tablets and rh-TSH injections prior to second RI uptake measurement
rhTSH
The patients will be randomised to either T3 (Liothyronine) pause related to the first radioiodine treatment and Thyrogen injection with continuing Liothyronine treatment related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.
rh-TSH
To continue with L-T3 and to receive rh-TSH stimulation with 0,9 mg Thyrogen® (Genzyme) x 2 days minus 1 and 2 prior to RI therapy, and following this to have placebo tablets and placebo injections with isotone NaCl prior to the RI uptake measurement 4-6 months later
rhTSH
The patients will be randomised to either T3 (Liothyronine) pause related to the first radioiodine treatment and Thyrogen injection with continuing Liothyronine treatment related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.
Interventions
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rhTSH
The patients will be randomised to either T3 (Liothyronine) pause related to the first radioiodine treatment and Thyrogen injection with continuing Liothyronine treatment related to the second treatment/uptake - or Thyrogen related to the first treatment and T3 pause related to the second treatment /uptake.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant or lactating women
18 Years
75 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Principal Investigators
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Birte Nygaard, Md, PhD
Role: STUDY_CHAIR
dept of endocrinology,Herlev Hospital
Locations
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Dept of Oncology, Herlev Hospital
Herlev, Herlev, Denmark
Countries
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Other Identifiers
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2007-002713-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HB-2007-043
Identifier Type: REGISTRY
Identifier Source: secondary_id
Data register 2007-41-120
Identifier Type: REGISTRY
Identifier Source: secondary_id
Dathyrca 1
Identifier Type: -
Identifier Source: org_study_id
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