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

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ClinicalTrials.gov Identifier: NCT02665325
Recruitment Status : Unknown
Verified June 2016 by The Affiliated Hospital of Inner Mongolia Medical University.
Recruitment status was:  Recruiting
First Posted : January 27, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
The Affiliated Hospital of Inner Mongolia Medical University

Study Description
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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.

Condition or disease Intervention/treatment
Cognitive Impairment Drug: TSH-suppressive therapy

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Functions and Mood During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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 Name: Thyroidectomy
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.


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive impairment assessed with the Mini-Mental State Examination (MMSE) [ Time Frame: 2 years ]
  2. Cognitive impairment assessed with the Clock Drawing Test (CDT) [ Time Frame: 2 years ]
  3. Cognitive impairment assessed with the Digit Symbol test (DST) [ Time Frame: 2 years ]
  4. Cognitive impairment assessed with the Wechsler Memory Scale (WMS) [ Time Frame: 2 years ]
  5. Cognitive impairment assessed with the Aphasia Battery of Chinese （ABC） [ Time Frame: 2 years ]
  6. Mood assessed with the patient health questionnaire -9 (PHQ-9) [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665325


Contacts
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Contact: Shan Jin, PhD +86-15849338280 jinshangood@163.com
Contact: Yun-Tian Yang, PhD +86-15849338737 yangyuntian@sina.com

Locations
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China, Inner Mongolia
Shan Jin Recruiting
Hohhot, Inner Mongolia, China, 010050
Contact: Shan Jin, PhD    +86-15849338280    jinshangood@163.com   
Contact: Yun-Tian Yang, PhD    +86-15849338737    yangyuntian@sina.com   
Sponsors and Collaborators
The Affiliated Hospital of Inner Mongolia Medical University
National Natural Science Foundation of China
Investigators
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Study Director: Shan Jin, PhD Affiliated Hospital of Inner Mongolia Medical University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: The Affiliated Hospital of Inner Mongolia Medical University
ClinicalTrials.gov Identifier: NCT02665325    
Other Study ID Numbers: AHInnerMongolia-Thyroid-01
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by The Affiliated Hospital of Inner Mongolia Medical University:
TSH-suppressive therapy
cognitive function
Additional relevant MeSH terms:
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Thyroid Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases