Clinical trial NCT06695936: Treatment with Intensity Modulated Radiotherapy on the Change of Cognitive Function in Nasopharyngeal Carcinoma Patients: a Prospective Cohort Study
Official title: Treatment with Intensity Modulated Radiotherapy on the Change of Cognitive Function in Nasopharyngeal Carcinoma Patients: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nasopharyngeal Carcinoma (NPC)
Cognitive Function
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Untreated newly diagnosed nasopharyngeal carcinoma patients without metastasis.

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.


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
* 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.

Primary outcomes:
measure: Incidence of cognitive decline.
timeFrame: 2 years
Secondary outcomes:
measure: The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.
timeFrame: 2 years
measure: The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.
timeFrame: 2 years
measure: The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy.
timeFrame: 2 years
measure: The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy.
timeFrame: 2 years
measure: The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline.
timeFrame: 2 years
measure: The correlation between cognitive decline after radiotherapy and quality of life.
timeFrame: 2 years
Other outcomes:
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