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

NCT02665325 | Unknown

• 1 other identifier: AHInnerMongolia-Thyroid-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Impairment

Keywords

TSH-suppressive therapy; cognitive function

Outcome Measures

Primary Outcomes (6)

• Cognitive impairment assessed with the Mini-Mental State Examination (MMSE)

  2 years

• Cognitive impairment assessed with the Clock Drawing Test (CDT)

  2 years

• Cognitive impairment assessed with the Digit Symbol test (DST)

  2 years

• Cognitive impairment assessed with the Wechsler Memory Scale (WMS)

  2 years

• Cognitive impairment assessed with the Aphasia Battery of Chinese （ABC）

  2 years

• Mood assessed with the patient health questionnaire -9 (PHQ-9)

  2 years

Study Arms (3)

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.

Drug: TSH-suppressive therapy

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.

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.

Interventions

TSH-suppressive therapy DRUG

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.

Also known as: Thyroidectomy

TSHsuppressive therapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Affiliated Hospital of Inner Mongolia Medical University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Shan Jin

Hohhot, Inner Mongolia, 010050, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 22278420 BACKGROUND

• 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.

  PMID: 20151821 BACKGROUND

• 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.

  PMID: 19248795 BACKGROUND

• 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.

  PMID: 19435829 BACKGROUND

• 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.

  PMID: 23108544 BACKGROUND

• 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.

  PMID: 16322379 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Shan Jin, PhD

  The Affiliated Hospital of Inner Mongolia Medical University

  STUDY DIRECTOR

Central Study Contacts

Shan Jin, PhD

CONTACT

+86-15849338280; jinshangood@163.com

Yun-Tian Yang, PhD

CONTACT

+86-15849338737; yangyuntian@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)