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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Function; Nasopharyngeal Carcinoma (NPC)

• Study Type: Observational
• Enrollment (Estimated): 329

Contacts and Locations

• Study Contact: Name: Haiqiang Mai, Dr; Phone Number: 86-20-8734-3643; Email: maihq@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Untreated newly diagnosed nasopharyngeal carcinoma patients without metastasis.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cognitive decline.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.	Statistical analysis will be conducted based on the changes in hippocampal volume before and after radiotherapy, tumor target dose, hippocampal irradiation dose, and cognitive function scale test results.	2 years
The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.	Using resting-state fMRI technology, individual local brain function and default network information will be obtained. Variance analysis will be used to compare hippocampal changes before and after radiotherapy, clarifying the relationship between hippocampal functional damage, radiation dose, and cognitive function post-radiotherapy.	2 years
The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy.	Using Synthetic MRI imaging technology, imaging data of nasopharyngeal carcinoma patients will be collected before and after radiotherapy to provide individual whole-brain quantitative parameters and hippocampal microstructural information. Variance analysis will be used to compare pre- and post-radiotherapy differences, elucidating the relationship between hippocampal microstructural damage, radiation dose, and cognitive function.	2 years
The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy.	Based on multimodal MRI technology, this study will explore the microvascular status and changes in blood perfusion in nasopharyngeal carcinoma patients before and after radiotherapy, clarifying the relationship between hippocampal microvascular damage, radiation dose, and cognitive function post-radiotherapy.	2 years
The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline.	According to the TPS planning system dose statistics and dose-volume histogram, we will quantify the irradiation dose-volume of critical organs, including: hippocampal volume, tumor target volume, clinical target volume, and planning target volume; maximum dose and average dose of the hippocampus, as well as parameters on the dose-volume histogram. The cognitive function of patients after radiotherapy will be evaluated based on common adverse events as defined by CTCAE.	2 years
The correlation between cognitive decline after radiotherapy and quality of life.	"The quality of life will be prospectively assessed before treatment and followed up continuously after radiotherapy."	2 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): November 15, 2028
• Study Completion (Estimated): November 20, 2028

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma
• Other Study ID Numbers: 2024-FXY-132

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No