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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05824312
Other study ID # FJCH_HNS_QOL01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date January 31, 2026

Study information

Verified date April 2023
Source Fujian Cancer Hospital
Contact yu wu, doctor
Phone 13705003480
Email dr_wuyu@fjzlhospital.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).


Description:

Surgical resection is the cornerstone of treatment for thyroid cancer. However, some patients present with locally advanced disease at the time of diagnosis, and they are not eligible for radical resection. Another patients still had the risk of recurrence after surgery, endocrine therapy and iodine-131 treatment. Tyrosine kinase inhibitors (TKI) have been proved to be effective in thyroid cancer patients. However, it was still unclear whether TKI drugs had influence on the HRQOL of LATC patients. The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).Participants enroll the study after informed consent, and quality of life will be assessed using quality of life questionnaires EORTC QLQ C30, and EORTC THY 47 before surgery, and 1,3,6 and 12 months after treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date January 31, 2026
Est. primary completion date January 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients age (18-70 year old) - Diagnosis of locally advanced thyroid cancer - Patient receiving TKI drugs. Exclusion Criteria: - pregnancy or breastfeeding women; - history of other malignant diseases, unstable angina, myocardial infarction, cerebral infarction or cerebral hemorrhage within 6 months; (3) patients missing questionnaires greater than 3 times.

Study Design


Intervention

Drug:
Tyrosine kinase inhibitor drugs.
TKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks.

Locations

Country Name City State
China Road Fuma No.420 Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the global status of QLQ C30 questionnaire Change in global HRQOL score between baseline and at 12 months after treatment. A change of more than 10% is set as a limit for a significant change 1 year
Secondary Adversed events of TKI. all TKI-related adversed events during and after the treatment of TKI. 1 year
Secondary Change in fatigue score Change in fatigue score between start and at 12 months after thyroid treatment. A change of more than 10% is set as a limit for a significant change. 1 year
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