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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Cognitive Function; Nasopharyngeal Carcinoma (NPC)

Study type: Observational

Funder types: Other

Identifiers

NCT06695936

2024-FXY-132

Details and patient eligibility

About

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.

Enrollment: 329 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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
• period due to disease progression (including residual tumors after
• radiotherapy, tumor recurrence, or newly developed distant metastasis);
• Patients with diabetes or hypertension;
• Those unable to cooperate in completing neurocognitive scale testing;
• Those with other uncontrolled severe diseases.