Thyroid CancerPhase 4NCT00604318
Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
A Phase 4 study testing rhTSH in people with Thyroid Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- rhTSH
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Follicular or papillary thyroid cancer
Who cannot join
- < 18 or > 75 years old
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Thyroid Cancer
- Being tested
- rhTSH
- Keywords
- quality of life
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTSHDrug
Also called Thyrogen - GEnzyme
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.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 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 Receives: Drug: rhTSH |
| rh-TSH | Active comparator | 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 Receives: Drug: rhTSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Measured: month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Birte Nygaard, Md, PhD, Study chair, dept of endocrinology,Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604318
- Sponsor's protocol ID
- Dathyrca 1
- Other IDs
- 2007-002713-39, HB-2007-043, Data register 2007-41-120
- Status last verified
- Jan 2013
- First submitted
- 17 Jan 2008
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT00604318
- Acronym / sponsor ID
- Dathyrca 1
- Conditions
- Thyroid Cancer
- Keywords
- quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Feb 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: rhTSHTo 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 |
| rh-TSH | Active comparator | Drug: rhTSHTo 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Follicular or papillary thyroid cancer
Key exclusion criteria (2 listed)
- < 18 or > 75 years old
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTSHAlso: Thyrogen - GEnzymeThe 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. | Drug | placebo, rh-TSH |
Primary outcome
quality of life
Time frame: month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birte Nygaard, Md, PhD study chair
dept of endocrinology,Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhTSH in people with Thyroid Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.