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Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
This study is currently recruiting participants.
Verified June 2011 by Copenhagen University Hospital at Herlev

First Received on January 17, 2008.   Last Updated on June 28, 2011   History of Changes
Sponsor: Copenhagen University Hospital at Herlev
Collaborator: Odense University Hospital
Information provided by: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT00604318
  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: Thyrogen combinated with continuing Liothyronine treatment
 Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
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:

MedlinePlus related topics: Cancer Thyroid Cancer Thyroid Diseases
Drug Information available for: Liothyronine sodium Thyrotropin alfa Triiodothyronine Thyroid Thyrotropin
U.S. FDA Resources

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

Primary Outcome Measures:
  • quality of life [ Time Frame: month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
stopping the usual T3 treatment (Liothyronine) and by this increase in s-TSH
 Drug: Thyrogen combinated with continuing Liothyronine treatment
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
Experimental: 2
continuous T3 treatment (Liothyronine) and recombinant TSH
 Drug: Thyrogen combinated with continuing Liothyronine treatment
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604318

Contacts
Contact: Birte Nygaard, Md, PhD +45 44883655 binyg@heh.regionh.dk
Contact: Jens Bentzen jeben@heh.regionh.dk

Locations
Denmark
Dept of Oncology, Herlev Hospital Recruiting
Herlev, Denmark, dk- 2730
Contact: Jens Bentzen, Md         jeben@heh.regionh.dk    
Principal Investigator: Jens Bentzen, MD            
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

No publications provided

Responsible Party: Birte Nygaard, Md PhD, Department of Endocrinology, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00604318     History of Changes
Other Study ID Numbers: Dathyrca 1, EudrCT 2007-002713-39, HB-2007-043, Data register 2007-41-120
Study First Received: January 17, 2008
Last Updated: June 28, 2011
Health Authority: Denmark: Danish Medicines Agency;   Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on February 09, 2012



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