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

Thyroid Cancer Clinical Trial

Official title:

Evaluation of The Development of Central Resistance to Thyroid Hormone After Prolonged Exposure to Excess Thyroid Hormone in Thyroid Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04868045
• Other study ID #: 20-079
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 27, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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).

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Thyrotropin Releasing Hormone (TRH)
TRH administration will be given as a 200-mcg single IV bolus on Day 1 and Day 5.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 5

External Links

•   Memorial Sloan Kettering Cancer Center