Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
Information source: Copenhagen University Hospital at Herlev
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thyroid Cancer
Intervention: rhTSH (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Copenhagen University Hospital at Herlev Official(s) and/or principal investigator(s):
Birte Nygaard, Md, PhD, Study Chair, Affiliation: dept of endocrinology,Herlev Hospital
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.
Clinical Details
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?
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: quality of life
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Follicular or papillary thyroid cancer
Exclusion Criteria:
- < 18 or > 75 years old
- Pregnant or lactating women
Locations and Contacts
Dept of Oncology, Herlev Hospital, Herlev dk- 2730, Denmark
Additional Information
Starting date: February 2008
Last updated: January 9, 2013
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