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Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04868045
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: Thyrotropin Releasing Hormone (TRH) Drug: levothyroxine Other: Hypothyroidism QOL questionnaire Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Evaluation of The Development of Central Resistance to Thyroid Hormone After Prolonged Exposure to Excess Thyroid Hormone in Thyroid Cancer Patients
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023


Arm Intervention/treatment
Experimental: Patients with a history of thyroid hormone suppression (TSH<0.5 mU/L) for at least 5 years
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.
Drug: Thyrotropin Releasing Hormone (TRH)
TRH administration will be given as a 200-mcg single IV bolus on Day 1 and Day 5.

Drug: levothyroxine

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.


Other: Hypothyroidism QOL questionnaire
Administer standardized Hypothyroidism QOL questionnaire.

Experimental: Patients with no history of TSH suppression
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.
Drug: Thyrotropin Releasing Hormone (TRH)
TRH administration will be given as a 200-mcg single IV bolus on Day 1 and Day 5.

Drug: levothyroxine

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.


Other: Hypothyroidism QOL questionnaire
Administer standardized Hypothyroidism QOL questionnaire.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Due to a diagnosis of thyroid cancer based on pathology patient underwent a total thyroidectomy
  • 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.

Exclusion Criteria:

  • 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
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04868045


Contacts
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Contact: Stephanie Fish, MD 646-888-3274 fishs@mskcc.org
Contact: James Fagin, MD 646-608-2921

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Stephanie J. Fish, MD    646-888-3274      
Contact: James Fagin, MD    646-608-2921      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Stephanie Fish, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04868045    
Other Study ID Numbers: 20-079
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Thyrotropin Releasing Hormone (TRH)
20-079
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Hormones
Thyrotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs