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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?


Phase 4
18 Years
75 Years
Not Enrolling
Both
Thyroid Cancer

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Trial Information

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?


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.


Inclusion Criteria:



- Follicular or papillary thyroid cancer

Exclusion Criteria:

- < 18 or > 75 years old

- Pregnant or lactating women

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

quality of life

Outcome Time Frame:

month

Safety Issue:

Yes

Principal Investigator

Birte Nygaard, Md, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

dept of endocrinology,Herlev Hospital

Authority:

Denmark: Danish Medicines Agency

Study ID:

Dathyrca 1

NCT ID:

NCT00604318

Start Date:

February 2008

Completion Date:

February 2012

Related Keywords:

  • Thyroid Cancer
  • quality of life
  • Thyroid Neoplasms
  • Thyroid Diseases

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