HRQOL in Locally Advanced Thyroid Carcinoma

Thyroid Cancer Clinical Trial

— LATCQOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824312
• Other study ID #: FJCH_HNS_QOL01
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Health Related Quality of Life
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Tyrosine Kinase Inhibitor

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