Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
Primary Purpose
Thyroid Cancer
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
rhTSH
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer focused on measuring quality of life
Eligibility Criteria
Inclusion Criteria:
- Follicular or papillary thyroid cancer
Exclusion Criteria:
- < 18 or > 75 years old
- Pregnant or lactating women
Sites / Locations
- Dept of Oncology, Herlev Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
rh-TSH
Arm Description
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
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
Outcomes
Primary Outcome Measures
quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT00604318
First Posted
January 17, 2008
Last Updated
January 9, 2013
Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00604318
Brief Title
Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
rh-TSH
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
rhTSH
Other Intervention Name(s)
Thyrogen - GEnzyme
Intervention Description
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.
Primary Outcome Measure Information:
Title
quality of life
Time Frame
month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Follicular or papillary thyroid cancer
Exclusion Criteria:
< 18 or > 75 years old
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birte Nygaard, Md, PhD
Organizational Affiliation
dept of endocrinology,Herlev Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of Oncology, Herlev Hospital
City
Herlev
ZIP/Postal Code
dk- 2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
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