Impact of TSH-suppressive therapy on cognitive functions in thyroid cancer patients
Cognitive Functions and Mood During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma
The Affiliated Hospital of Inner Mongolia Medical University · NCT02665325
This study is testing how TSH-suppressive therapy affects thinking and mood in thyroid cancer patients who have had surgery, to see if the treatment causes any cognitive issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Inner Mongolia Medical University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hohhot, Inner Mongolia) |
| Trial ID | NCT02665325 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of TSH-suppressive therapy on cognitive functions and mood in patients with differentiated thyroid carcinoma (DTC) who have undergone thyroidectomy. It aims to explore the potential cognitive impairment associated with subclinical hyperthyroidism induced by L-thyroxine treatment. The study will involve neuropsychological assessments and serum level evaluations of thyroid hormones and antibodies after 6 and 12 months of therapy. Healthy volunteers will also be recruited for comparison based on age, gender, and education level.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with newly diagnosed differentiated thyroid carcinoma who have undergone thyroidectomy and are receiving TSH-suppressive therapy.
Not a fit: Patients with pre-existing central nervous system disorders or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into cognitive health management for patients undergoing TSH-suppressive therapy, potentially leading to improved treatment protocols.
How similar studies have performed: While there is limited research specifically on TSH-suppressive therapy's impact on cognitive function, similar studies on thyroid hormone effects have shown varying results, indicating this area is still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Hohhot, Inner Mongolia
- Shan Jin — Hohhot, Inner Mongolia, China (RECRUITING)
Study contacts
- Study coordinator: Shan Jin, PhD
- Email: jinshangood@163.com
- Phone: +86-15849338280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cognitive Impairment, TSH-suppressive therapy, cognitive function