Cognitive Functions and Mood During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cognitive impairment assessed with the Aphasia Battery of Chinese （ABC）
研究概览
简要总结
Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become the malignant neoplasm of fastest growing incidence rate. More than 90% thyroid carcinoma is thyroid differentiated carcinoma（DTC）. Postoperative oral L-thyroxine suppressing thyroid stimulating hormone (TSH) treatment is the standard therapy in DTC patients. While TSH-suppressive therapy with L-thyroxine can cause subclinical hyperthyroidism in treatment of patients with thyroid differentiated carcinoma. The impact of this therapy on cognitive functions and mood have not been systematically studied. The investigators infer the subclinical hyperthyroidism caused by TSH-suppressive therapy may impact cognitive function and mood disorders in DTC patients. The aim of this study is to explore the possible mechanism of cognitive function impairment in the course of TSH-suppressive therapy by rat model of total thyroidectomy + TSH-suppressive therapy and clinical trials. The result of this study may provide clinical and experimental basis for the side effects risk result form TSH-suppressive therapy in DTC patients.
详细描述
- Object:
Patients aged 18-65 years; newly diagnosed differentiated thyroid carcinoma and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months. 2. Clinical information, examination data and neuropsychological assessments:
Information is obtained from medical record abstraction. Serum T3, T4, FT3, FT4, TSH, TG-ab, TPO-ab, TG levels and neuropsychological assessments are examined after TSH-suppressive therapy 6 /12 months. Cognitive complaints were assessed with the Mini-Mental State Examination (MMSE), Clock Drawing Test (CDT), Digit Symbol test (DST), Wechsler Memory Scale (WMS), Aphasia Battery of Chinese （ABC） and patient health questionnaire-9 (PHQ-9).
Healthy volunteers (normal T3, T4, FT3, FT4, TSH, TG-ab, TPO-ab, TG) are recruited to match the patients with age, gender, education level, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed differentiated thyroid carcinoma.
- •Undergo thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer.
- •Followed by TSH-suppressive therapy 6 /12 months.
排除标准
- •Current or past disorder/disease of the central nervous system or medical condition impacting cognitive functioning.
- •Head trauma history with prolonged loss of consciousness.
- •Epilepsy, dementia, or learning disability.
- •Current or past psychotic-spectrum disorder or current major affective disorder.
- •Current substance abuse/dependence.
- •Daily tobacco and alcohol use.
- •Whole brain irradiation or surgery.
- •Prior cancer diagnosis or chemotherapy treatment.
- •Active autoimmune disorder.
- •Insulin-dependent diabetes.
- •Uncontrolled allergic condition or asthma.
- •Chronic use of oral steroid medication.
- •Hormone therapy (estrogen, progestin compounds).
研究组 & 干预措施
TSHsuppressive therapy group
TSH-suppressive therapy group: newly diagnosed differentiated thyroid carcinoma and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months.
干预措施: TSH-suppressive therapy (Drug)
结局指标
主要结局
Cognitive impairment assessed with the Aphasia Battery of Chinese （ABC）
时间窗: 2 years
Cognitive impairment assessed with the Mini-Mental State Examination (MMSE)
时间窗: 2 years
Cognitive impairment assessed with the Wechsler Memory Scale (WMS)
时间窗: 2 years
Cognitive impairment assessed with the Clock Drawing Test (CDT)
时间窗: 2 years
Cognitive impairment assessed with the Digit Symbol test (DST)
时间窗: 2 years
Mood assessed with the patient health questionnaire -9 (PHQ-9)
时间窗: 2 years
次要结局
未报告次要终点