Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
Information source: Copenhagen University Hospital at Herlev
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thyroid Cancer
Intervention: Thyrogen combinated with continuing Liothyronine treatment (Drug)
Phase: Phase 4
Status: Recruiting
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
Overall contact:
Birte Nygaard, Md, PhD, Phone: +45 44883655, Email: binyg@heh.regionh.dk
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: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Crossover Assignment
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
Birte Nygaard, Md, PhD, Phone: +45 44883655, Email: binyg@heh.regionh.dk
Dept of Oncology, Herlev Hospital, Herlev dk- 2730, Denmark; Recruiting
Jens Bentzen, Md, Email: jeben@heh.regionh.dk
Jens Bentzen, MD, Principal Investigator
Additional Information
Starting date: February 2008
Ending date: February 2012
Last updated: August 28, 2009
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