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

This study has been completed.

Sponsor:

Collaborator:

Odense University Hospital

Information provided by (Responsible Party):

Copenhagen University Hospital at Herlev

ClinicalTrials.gov Identifier:

NCT00604318

First received: January 17, 2008

Last updated: January 9, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 17, 2008

Last Updated Date

January 9, 2013

Start Date ^ICMJE

February 2008

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

quality of life [ Time Frame: month ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00604318 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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?

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Thyroid Cancer

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Drug: rhTSH
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

Intervention: Drug: rhTSH

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Follicular or papillary thyroid cancer

Exclusion Criteria:

< 18 or > 75 years old
Pregnant or lactating women

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00604318

Other Study ID Numbers ^ICMJE

Dathyrca 1, 2007-002713-39, HB-2007-043, Data register 2007-41-120

Has Data Monitoring Committee

Yes

Responsible Party

Copenhagen University Hospital at Herlev

Study Sponsor ^ICMJE

Copenhagen University Hospital at Herlev

Collaborators ^ICMJE

Odense University Hospital

Investigators ^ICMJE

Study Chair:

Birte Nygaard, Md, PhD

dept of endocrinology,Herlev Hospital

Information Provided By

Copenhagen University Hospital at Herlev

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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