Treatment with Intensity Modulated Radiotherapy on the Change of Cognitive Function in Nasopharyngeal Carcinoma Patients: a Prospective Cohort Study

Sun Yat-sen University0 sites329 target enrollmentNovember 15, 2024

ConditionsNasopharyngeal Carcinoma (NPC)Cognitive Function

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nasopharyngeal Carcinoma (NPC)
Sponsor: Sun Yat-sen University
Enrollment: 329
Primary Endpoint: Incidence of cognitive decline.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is an observational cohort study aimed at investigating changes in hippocampal function and its impact on cognitive function in newly diagnosed nasopharyngeal carcinoma patients without metastasis, from baseline to a period after radiotherapy.

Registry

clinicaltrials.gov

Start Date

November 15, 2024

End Date

November 20, 2028

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Hai-Qiang Mai,MD,PhD

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Newly diagnosed nasopharyngeal carcinoma patients confirmed by pathology, who have not received surgical, induction chemotherapy, radiotherapy, or other anti-tumor treatments;
•Clinical stage classified as AJCC 8th edition Stage I-IVa, with no distant metastasis, and who are scheduled to undergo intensity-modulated radiotherapy (IMRT) according to clinical plans;
•Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III);
•All participants are Han Chinese and right-handed;
•Age between 18 and 60 years, with an education level of junior high school or above;
•No history of neurological diseases or head trauma;
•No other severe systemic diseases other than nasopharyngeal carcinoma;
•No hippocampal invasion before treatment;
•Routine MRI before treatment shows no abnormal lesions in the hippocampus;
•No family history of mental illness.

Exclusion Criteria

•Routine MRI before treatment shows abnormal lesions in the hippocampus;
•Contraindications for magnetic resonance examination;
•Concurrent other brain diseases;
•Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO type I);
•Patients with recurrence or distant metastasis;
•Patients who have previously undergone radiotherapy or chemotherapy;
•Abnormal function of vital organs such as heart, brain, or lungs;
•History of head trauma or mental/neuro diseases;
•Age less than 18 years or greater than 60 years;
•Patients whose initial treatment plan is changed during the observation

Outcomes

Primary Outcomes

Incidence of cognitive decline.

Time Frame: 2 years

In a cohort of nasopharyngeal carcinoma patients undergoing intensity-modulated radiotherapy, we will observe the incidence of cognitive decline from baseline, at the end of radiotherapy, and post-treatment. The study will investigate the impact of hippocampal radiation dose on cognitive function in these patients and summarize the patterns of change.

Secondary Outcomes

The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.(2 years)
The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.(2 years)
The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy.(2 years)
The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy.(2 years)
The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline.(2 years)
The correlation between cognitive decline after radiotherapy and quality of life.(2 years)