HRQOL in Locally Advanced Thyroid Carcinoma

Recruiting

• Conditions: Health Related Quality of Life; Tyrosine Kinase Inhibitor; Thyroid Cancer
• Interventions: Drug: Tyrosine kinase inhibitor drugs.

• Registration Number: NCT05824312
• Lead Sponsor: Fujian Cancer Hospital

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-03-28
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2025-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients age (18-70 year old)
• Diagnosis of locally advanced thyroid cancer
• Patient receiving TKI drugs.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TKI group	Tyrosine kinase inhibitor drugs.	patients with LATC receiving Tyrosine kinase inhibitor drugs.

Primary Outcome Measures

Name	Time	Method
the global status of QLQ C30 questionnaire	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 Outcome Measures

Name	Time	Method
Change in fatigue score	1 year	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.
Adversed events of TKI.	1 year	all TKI-related adversed events during and after the treatment of TKI.

Trial Locations

Locations (1)

Road Fuma No.420; 🇨🇳 Fuzhou, Fujian, China