Thyroid CancerPhase 1NCT04868045
Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer
A Phase 1 study testing Thyrotropin Releasing Hormone (TRH), levothyroxine and Hypothyroidism QOL questionnaire in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center.
Trial summary
The purpose of this study is to find out whether people who have had thyroid cancer develop resistance to treatment with thyroid hormones after having received high doses of thyroid drugs for many years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Thyrotropin Releasing Hormone (TRH), levothyroxine and Hypothyroidism QOL questionnaire
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2021to 15 Feb 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Due to a diagnosis of thyroid cancer, patient underwent a total thyroidectomy based on pathology.
- No evidence of active disease based on routine surveillance testing showing no suspicious findings on neck ultrasound and low thyroglobulin levels (≤1.0 ng/ml) with negative thyroglobulin antibodies within one year of study enrollment. For the study patients, this response can be evaluated after five years of TSH suppression. For control subjects, this response can be evaluated after two years of surveillance.
- Two groups:
- 8 patients with a history of thyroid hormone suppression (TSH<0.5 mU/L) for at least 5 years
- 8 patients with no history of TSH suppression
- Normal TSH level based on the laboratory reference range for at least 6 months at the time of study enrollment.
- Blood pressure range of >90/60 and <180/100. Patients may be included in the study if blood pressure has been treated with medication and normalized.
Who cannot join
- Patient reported history of symptomatic heart disease including unstable angina or NYHA stage III or IV heart failure.
- Patient reported history of one of the following cardiac arrhythmias: atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, ventricular fibrillation, or ventricular tachycardia.
- Patient reported history of uncontrolled hypotension (<90/60) or hypertension (>180/100).
- History of renal dysfunction with creatinine more than 1.5 times the upper limit of normal based on recent laboratory testing
- Known hypersensitivity to the drug
- Pregnant or breast feeding
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- Prior history of seizures or brain damage
- Patients on chronic therapy with levodopa
- Patients on therapeutic doses of acetylsalicylic acid (2 - 3.6 gm/day)
- Patients with conditions that result in disruption of the hypothalamic-pituitary axis (i.e. hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma).
About this study
Official title: Evaluation of The Development of Central Resistance to Thyroid Hormone After Prolonged Exposure to Excess Thyroid Hormone in Thyroid Cancer Patients
The purpose of this study is to find out whether people who have had thyroid cancer develop resistance to treatment with thyroid hormones after having received high doses of thyroid drugs for many years.
- Conditions
- Thyroid Cancer
- Being tested
- Thyrotropin Releasing Hormone (TRH), levothyroxine, Hypothyroidism QOL questionnaire
- Keywords
- Thyrotropin Releasing Hormone (TRH), 20-079
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyrotropin Releasing Hormone (TRH)Drug
TRH administration will be given as a 200-mcg single IV bolus on Day 1 and Day 5.
levothyroxineDrug
Patients maintenance dose of levothyroxine will be taken throughout the study. On Day
1 and Day 5, the levothyroxine will be taken after the TRH test is complete. On Days 2- 4, the levothyroxine will be taken in the morning.
Hypothyroidism QOL questionnaireOther
Administer standardized Hypothyroidism QOL questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a history of thyroid hormone suppression (TSH<0.5 mU/L) for at least 5 years | Experimental | Study subjects will be given 200mcg of TRH as a single intravenous (IV) bolus in endocrine clinic on Day 1 and Day 5. LT3 will be administered orally, twice a day (12 hours apart i.e. 8 AM and 8 PM) at a dosage of 10 mcg on Day 2-4. Levothyroxine will be taken after the TRH stimulation tests on Day 1 and day 5. Levothyroxine will be taken on Days 2-4 of the study. *Patients will take their own LT4 that they are prescribed by their endocrinologist. The dose of Levothyroxine is titrated for each patient. Receives: Drug: Thyrotropin Releasing Hormone (TRH); Drug: levothyroxine; Other: Hypothyroidism QOL questionnaire |
| Patients with no history of TSH suppression | Experimental | Study subjects will be given 200mcg of TRH as a single intravenous (IV) bolus in endocrine clinic on Day 1 and Day 5. LT3 will be administered orally, twice a day (12 hours apart i.e. 8 AM and 8 PM) at a dosage of 10 mcg on Day 2-4. Levothyroxine will be taken after the TRH stimulation tests on Day 1 and day 5. Levothyroxine will be taken on Days 2-4 of the study. *Patients will take their own LT4 that they are prescribed by their endocrinologist. The dose of Levothyroxine is titrated for each patient. Receives: Drug: Thyrotropin Releasing Hormone (TRH); Drug: levothyroxine; Other: Hypothyroidism QOL questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in peak TSH levels
in response to TRH stimulation between day 1 (baseline) and day 5 after three days of high dose LT3 treatment.
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start27 Apr 2021
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Why it stopped: Lack of accrual
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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single center, pilot study of the hypothalamic-pituitary-thyroid axis in adult patients with thyroid cancer.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Fish, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868045
- Sponsor's protocol ID
- 20-079
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Development of Central Resistance to Thyroid Hormone After Prolonged Exposure to Excess Thyroid Hormone in Thyroid Cancer Patients
- ClinicalTrials.gov ID
- NCT04868045
- Acronym / sponsor ID
- 20-079
- Conditions
- Thyroid Cancer
- Keywords
- Thyrotropin Releasing Hormone (TRH), 20-079
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 30 Apr 2021 (actual)
- 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.
The purpose of this study is to find out whether people who have had thyroid cancer develop resistance to treatment with thyroid hormones after having received high doses of thyroid drugs for many years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, single center, pilot study of the hypothalamic-pituitary-thyroid axis in adult patients with thyroid cancer.
| Arm | Type | Receives |
|---|---|---|
| Patients with a history of thyroid hormone suppression (TSH<0.5 mU/L) for at least 5 years | Experimental | Drug: Thyrotropin Releasing Hormone (TRH), Drug: levothyroxine, Other: Hypothyroidism QOL questionnaireStudy subjects will be given 200mcg of TRH as a single intravenous (IV) bolus in endocrine clinic on Day 1 and Day 5. LT3 will be administered orally, twice a day (12 hours apart i.e. 8 AM and 8 PM) at a dosage of 10 mcg on Day 2-4. Levothyroxine will be taken after the TRH stimulation tests on Day 1 and day 5. Levothyroxine will be taken on Days 2-4 of the study. *Patients will take their own LT4 that they are prescribed by their endocrinologist. The dose of Levothyroxine is titrated for each patient. |
| Patients with no history of TSH suppression | Experimental | Drug: Thyrotropin Releasing Hormone (TRH), Drug: levothyroxine, Other: Hypothyroidism QOL questionnaireStudy subjects will be given 200mcg of TRH as a single intravenous (IV) bolus in endocrine clinic on Day 1 and Day 5. LT3 will be administered orally, twice a day (12 hours apart i.e. 8 AM and 8 PM) at a dosage of 10 mcg on Day 2-4. Levothyroxine will be taken after the TRH stimulation tests on Day 1 and day 5. Levothyroxine will be taken on Days 2-4 of the study. *Patients will take their own LT4 that they are prescribed by their endocrinologist. The dose of Levothyroxine is titrated for each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or older
- Due to a diagnosis of thyroid cancer, patient underwent a total thyroidectomy based on pathology.
- No evidence of active disease based on routine surveillance testing showing no suspicious findings on neck ultrasound and low thyroglobulin levels (≤1.0 ng/ml) with negative thyroglobulin antibodies within one year of study enrollment. For the study patients, this response can be evaluated after five years of TSH suppression. For control subjects, this response can be evaluated after two years of surveillance.
- Two groups:
- Normal TSH level based on the laboratory reference range for at least 6 months at the time of study enrollment.
Key exclusion criteria (10 listed)
- Patient reported history of symptomatic heart disease including unstable angina or NYHA stage III or IV heart failure.
- Patient reported history of one of the following cardiac arrhythmias: atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, ventricular fibrillation, or ventricular tachycardia.
- Patient reported history of uncontrolled hypotension (<90/60) or hypertension (>180/100).
- History of renal dysfunction with creatinine more than 1.5 times the upper limit of normal based on recent laboratory testing
- Known hypersensitivity to the drug
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 |
|---|---|---|
| Thyrotropin Releasing Hormone (TRH)TRH administration will be given as a 200-mcg single IV bolus on Day 1 and Day 5. | Drug | Patients with a history of thyroid hormone suppression (TSH<0.5 mU/L) for at least 5 years, Patients with no history of TSH suppression |
| levothyroxinePatients maintenance dose of levothyroxine will be taken throughout the study. On Day 1 and Day 5, the levothyroxine will be taken after the TRH test is complete. On Days 2- 4, the levothyroxine will be taken in the morning. | Drug | Patients with a history of thyroid hormone suppression (TSH<0.5 mU/L) for at least 5 years, Patients with no history of TSH suppression |
| Hypothyroidism QOL questionnaireAdminister standardized Hypothyroidism QOL questionnaire. | Other | Patients with a history of thyroid hormone suppression (TSH<0.5 mU/L) for at least 5 years, Patients with no history of TSH suppression |
Primary outcome
change in peak TSH levels
Time frame: day 5
in response to TRH stimulation between day 1 (baseline) and day 5 after three days of high dose LT3 treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Stephanie Fish, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thyrotropin Releasing Hormone (TRH), levothyroxine and Hypothyroidism QOL questionnaire in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center.
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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
change in peak TSH levels (time frame: day 5). 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 21 Feb 2023.