Cognitive Functions During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma
NCT ID: NCT02665325
Last Updated: 2023-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2016-01-31
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Negative control group
Healthy volunteers (normal T3,T4,FT3,FT4,TSH, TG-ab,TPO-ab,TG) are recruited to match the patients with age, gender, education level, ect.
No interventions assigned to this group
Positive control group
Newly diagnosed nodular goiter and undergone thyroidectomy according to the China thyroid association guidelines for the management of thyroid nodule and thyroid cnacer; followed by L-T4 replacement therapy 6/12 months.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
65 Years
ALL
Yes
Sponsors
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National Natural Science Foundation of China
OTHER_GOV
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
Responsible Party
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Principal Investigators
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Shan Jin, PhD
Role: STUDY_DIRECTOR
The Affiliated Hospital of Inner Mongolia Medical University
Locations
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Shan Jin
Hohhot, Inner Mongolia, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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: 10.1530/eje.1.02025.
Other Identifiers
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AHInnerMongolia-Thyroid-01
Identifier Type: -
Identifier Source: org_study_id
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