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Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604318
First Posted: January 30, 2008
Last Update Posted: January 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
  Purpose
To evaluate quality of life in patients after 10 days pause of thyroid medication (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine uptake and treatment in a double-blinded, randomised cross-over design.

Condition Intervention Phase
Thyroid Cancer Drug: rhTSH Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Is it Possible to Increase Quality of Life, Using Recombinant TSH Instead of Withdrawal of Thyroid Hormone Treatment, Before Iodine Uptake in Patients With Thyroid Cancer?

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • quality of life [ Time Frame: month ]

Enrollment: 56
Study Start Date: February 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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
Drug: 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 Name: Thyrogen - GEnzyme
Active Comparator: 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
Drug: 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 Name: Thyrogen - GEnzyme

Detailed Description:

Patients with a thyroid follicular or papillary cancer referred to radioiodine treatment in oncological department . The patients after thyroidectomy will be treated with Liothyronine and this treatment will be paused 10 days before radioiodine. As a routine these patients will be re-evaluated with iodine uptake 4 months later.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Follicular or papillary thyroid cancer

Exclusion Criteria:

  • < 18 or > 75 years old
  • Pregnant or lactating women
  Contacts and Locations
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): NCT00604318


Locations
Denmark
Dept of Oncology, Herlev Hospital
Herlev, Denmark, dk- 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Odense University Hospital
Investigators
Study Chair: Birte Nygaard, Md, PhD dept of endocrinology,Herlev Hospital
  More Information

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT00604318     History of Changes
Other Study ID Numbers: Dathyrca 1
2007-002713-39 ( EudraCT Number )
HB-2007-043 ( Registry Identifier: Danish Etical commity )
Data register 2007-41-120 ( Registry Identifier: Danish Data Protection )
First Submitted: January 17, 2008
First Posted: January 30, 2008
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by Copenhagen University Hospital at Herlev:
quality of life

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms