LATCQOL: HRQOL in Locally Advanced Thyroid Carcinoma

Sponsor

Fujian Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05824312

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.).

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer Tyrosine Kinase Inhibitor Health Related Quality of Life	Drug: Tyrosine kinase inhibitor drugs.

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
TKI group patients with LATC receiving Tyrosine kinase inhibitor drugs.	Drug: Tyrosine kinase inhibitor drugs. TKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks. Other Names: TKI treatment
Controlled group patients with LATC receiving other treatment.

Arm

Intervention/Treatment

TKI group

patients with LATC receiving Tyrosine kinase inhibitor drugs.

Drug: Tyrosine kinase inhibitor drugs.

TKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks.

Other Names:

TKI treatment

Controlled group

patients with LATC receiving other treatment.

Outcome Measures

Primary Outcome Measures

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

Adversed events of TKI. [1 year]
all TKI-related adversed events during and after the treatment of TKI.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

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.