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Clinical Trials/NCT05824312
NCT05824312
Recruiting
N/A

Health-related Quality of Life of Patients With Locally Advanced Thyroid Cancer Receiving Targeted Therapy

Fujian Cancer Hospital1 site in 1 country80 target enrollmentFebruary 1, 2023

Overview

Phase
N/A
Intervention
Tyrosine kinase inhibitor drugs.
Conditions
Thyroid Cancer
Sponsor
Fujian Cancer Hospital
Enrollment
80
Locations
1
Primary Endpoint
the global status of QLQ C30 questionnaire
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.).

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
January 31, 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

TKI group

patients with LATC receiving Tyrosine kinase inhibitor drugs.

Intervention: Tyrosine kinase inhibitor drugs.

Outcomes

Primary Outcomes

the global status of QLQ C30 questionnaire

Time Frame: 1 year

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

Secondary Outcomes

  • Change in fatigue score(1 year)
  • Adversed events of TKI.(1 year)

Study Sites (1)

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