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Not yet recruiting NCT06695936

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

— Observational Nasopharyngeal Carcinoma (NPC) Cognitive Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma (NPC), Cognitive Function. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Incidence of cognitive decline. [Time frame: 2 years]
Secondary outcome measures (6)
  • The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy. [Time frame: 2 years]
  • The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy. [Time frame: 2 years]
  • The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy. [Time frame: 2 years]
  • The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy. [Time frame: 2 years]
  • The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline. [Time frame: 2 years]
  • The correlation between cognitive decline after radiotherapy and quality of life. [Time frame: 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06695936 · 2024-FXY-132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗