Cognitive Functions During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma

Cognitive Impairment Clinical Trial

Official title:

Cognitive Functions and Mood During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02665325
• Other study ID #: AHInnerMongolia-Thyroid-01
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: The Affiliated Hospital of Inner Mongolia Medical University
• Contact: Shan Jin, PhD
• Phone: +86-15849338280
• Email: jinshangood[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

1. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Cognitive Impairment
• Thyroid Neoplasms

Intervention

Drug:
• TSH-suppressive therapy
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.

Locations

Country	Name	City	State
China	Shan Jin	Hohhot	Inner Mongolia

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Hospital of Inner Mongolia Medical University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (6)

Bauer M, Silverman DH, Schlagenhauf F, London ED, Geist CL, van Herle K, Rasgon N, Martinez D, Miller K, van Herle A, Berman SM, Phelps ME, Whybrow PC. Brain glucose metabolism in hypothyroidism: a positron emission tomography study before and after thyroid hormone replacement therapy. J Clin Endocrinol Metab. 2009 Aug;94(8):2922-9. doi: 10.1210/jc.2008-2235. Epub 2009 May 12. — View Citation

Biondi B, Cooper DS. Benefits of thyrotropin suppression versus the risks of adverse effects in differentiated thyroid cancer. Thyroid. 2010 Feb;20(2):135-46. doi: 10.1089/thy.2009.0311. — View Citation

Davis PJ, Zhou M, Davis FB, Lansing L, Mousa SA, Lin HY. Mini-review: Cell surface receptor for thyroid hormone and nongenomic regulation of ion fluxes in excitable cells. Physiol Behav. 2010 Feb 9;99(2):237-9. doi: 10.1016/j.physbeh.2009.02.015. Epub 2009 Feb 25. — View Citation

Fiore E, Vitti P. Serum TSH and risk of papillary thyroid cancer in nodular thyroid disease. J Clin Endocrinol Metab. 2012 Apr;97(4):1134-45. doi: 10.1210/jc.2011-2735. Epub 2012 Jan 25. — View Citation

Puighermanal E, Busquets-Garcia A, Maldonado R, Ozaita A. Cellular and intracellular mechanisms involved in the cognitive impairment of cannabinoids. Philos Trans R Soc Lond B Biol Sci. 2012 Dec 5;367(1607):3254-63. doi: 10.1098/rstb.2011.0384. — View Citation

Wekking EM, Appelhof BC, Fliers E, Schene AH, Huyser J, Tijssen JG, Wiersinga WM. Cognitive functioning and well-being in euthyroid patients on thyroxine replacement therapy for primary hypothyroidism. Eur J Endocrinol. 2005 Dec;153(6):747-53. doi: 10.153 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive impairment assessed with the Mini-Mental State Examination (MMSE)		2 years
Primary	Cognitive impairment assessed with the Clock Drawing Test (CDT)		2 years
Primary	Cognitive impairment assessed with the Digit Symbol test (DST)		2 years
Primary	Cognitive impairment assessed with the Wechsler Memory Scale (WMS)		2 years
Primary	Cognitive impairment assessed with the Aphasia Battery of Chinese (ABC)		2 years
Primary	Mood assessed with the patient health questionnaire -9 (PHQ-9)		2 years