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?”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Crossover Assignment

Study Primary Completion Date: February 2011

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • stopping the usual T3 treatment (Liothyronine) and by this increase in s-TSH
• Experimental: 2
  • continuous T3 treatment (Liothyronine) and recombinant TSH

Primary Measures

• quality of life
  • Time Frame: month
    Safety Issue?: Yes

Inclusion Criteria:

• Follicular or papillary thyroid cancer

Exclusion Criteria:

• < 18 or > 75 years old
• Pregnant or lactating women

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Copenhagen University Hospital at Herlev

Overall Clinical Trial Officials and Contacts

Birte Nygaard, Md, PhD Study Chair dept of endocrinology,Herlev Hospital  

Overall Contact: Birte Nygaard, Md, PhD +45 44883655 binyg@heh.regionh.dk

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00604318

Study ID Number: Dathyrca 1

ClinicalTrials.gov Identifier: NCT00604318

Health Authority: Denmark: Danish Medicines Agency