Clinical trial · Observational
Treatment with Intensity Modulated Radiotherapy on the Change of Cognitive Function in Nasopharyngeal Carcinoma Patients: a Prospective Cohort Study
NCT06695936CI-TRIAL-00082674not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Function | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma (NPC) | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of cognitive decline.
- timeFrame
- 2 years
- description
- 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 (6)
- measure
- The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.
- timeFrame
- 2 years
- description
- 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.
- measure
- The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.