Evaluation of The Development of Central Resistance to Thyroid Hormone After Prolonged Exposure to Excess Thyroid Hormone in Thyroid Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- change in peak TSH levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/
- •Patients may be included in the study if blood pressure has been treated with medication and normalized.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Thyrotropin Releasing Hormone (TRH) (Drug)
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.
干预措施: levothyroxine (Drug)
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.
干预措施: Hypothyroidism QOL questionnaire (Other)
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.
干预措施: Thyrotropin Releasing Hormone (TRH) (Drug)
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.
干预措施: levothyroxine (Drug)
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.
干预措施: Hypothyroidism QOL questionnaire (Other)
结局指标
主要结局
change in peak TSH levels
时间窗: day 5
in response to TRH stimulation between day 1 (baseline) and day 5 after three days of high dose LT3 treatment.
次要结局
未报告次要终点