NCT06695936尚未招募不适用
Treatment with Intensity Modulated Radiotherapy on the Change of Cognitive Function in Nasopharyngeal Carcinoma Patients: a Prospective Cohort Study
Sun Yat-sen University0 个研究点目标入组 329 人开始时间: 2024年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 329
- 主要终点
- Incidence of cognitive decline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of cognitive decline.
时间窗: 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.
次要结局
- The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.(2 years)
- The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.(2 years)
- The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy.(2 years)
- The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy.(2 years)
- The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline.(2 years)
- The correlation between cognitive decline after radiotherapy and quality of life.(2 years)
研究者
Hai-Qiang Mai,MD,PhD
Professor
Sun Yat-sen University
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