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NCT Number: NCT06695936

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of cognitive decline.

    Time frame: 2 years

    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

  1. The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.

    Time frame: 2 years

    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. The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.

    Time frame: 2 years

    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.

  3. The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy.

    Time frame: 2 years

    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.

  4. The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy.

    Time frame: 2 years

    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.

  5. The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline.

    Time frame: 2 years

    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.

  6. The correlation between cognitive decline after radiotherapy and quality of life.

    Time frame: 2 years

    "The quality of life will be prospectively assessed before treatment and followed up continuously after radiotherapy."

Study contacts

Contact information is provided by the study sponsor or research team.

Haiqiang Mai, Dr

CONTACT

[email protected]

86-20-8734-3643

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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