Thyroid Cancer
Conditions
Keywords
Thyrotropin Releasing Hormone (TRH), 20-079
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.
Interventions
TRH administration will be given as a 200-mcg single IV bolus on Day 1 and Day 5.
DRUGlevothyroxine
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.
OTHERHypothyroidism QOL questionnaire
Administer standardized Hypothyroidism QOL questionnaire.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a prospective, single center, pilot study of the hypothalamic-pituitary-thyroid axis in adult patients with thyroid cancer.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in peak TSH levels | day 5 | in response to TRH stimulation between day 1 (baseline) and day 5 after three days of high dose LT3 treatment. |
Outcome results
None listed