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临床试验/NCT07264023
NCT07264023尚未招募不适用

A Prospective, Observational, Multicenter Longitudinal Cohort Study on the Correlation Between Nutritional Status and Quality of Life in Children With Neuro-oncological Tumors During the Peri-radiotherapy Period.

Nanfang Hospital, Southern Medical University0 个研究点目标入组 93 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
93
主要终点
life quality

研究概览

简要总结

Maintaining good nutritional status during treatment for children with cancer is crucial for many outcomes, such as overall survival rate, tolerance to treatment, susceptibility to infection, and quality of life. Neurotumors in children account for the highest proportion among solid tumors in children. Previous studies have clearly shown that neurotumors in children have different nutritional characteristics from hematological tumors and other solid tumors in children. Our retrospective data found that there was a significant correlation between the BMI Z values of children with neurotumors before and during radiotherapy and the frequency of adverse events. The occurrence of adverse events has a negative impact on the quality of life of child patients. Therefore, we plan to conduct a prospective, observational, multi-center longitudinal cohort study to evaluate the dynamic changes in nutritional status during the peri-radiotherapy period, explore the correlation between nutritional status and quality of life in children with neurotumors before and after radiotherapy, and establish a nutritional management plan and nutritional risk early warning model suitable for Chinese children with neurotumors.

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
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The patient and the legal guardian have agreed to sign the informed consent form;
  • Age ≥ 5 years old and ≤ 18 years old;
  • The pathological or clinical diagnosis is a neurological tumor;
  • Patient has indications for radiotherapy;
  • The expected survival time is over 6 months.

排除标准

  • Accompanied by other serious complications;
  • The researcher judged that it was not suitable to participate in this study.

结局指标

主要结局

life quality

时间窗: Before radiotherapy, at the end of radiotherapy, one month after radiotherapy, three months after radiotherapy, six months after radiotherapy

The PedsQL Brain Tumor Module and the PedsQL4.0 Generic Core Scale for Children were used to assess the quality of life of the subjects. The assessment data were collected, including the children's self-assessment module and the parent proxy assessment module, covering dimensions such as physical function, emotional function, social function, and school function.

nutritional status

时间窗: Before radiotherapy, at the end of radiotherapy, one month after radiotherapy, three months after radiotherapy, and six months after radiotherapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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