NCT07264023

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Dec 2025May 2027

First Submitted

Initial submission to the registry

November 23, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

November 23, 2025

Last Update Submit

December 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • life quality

    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.

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

  • nutritional status

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

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children with neuro-oncological tumors

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 4, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

December 16, 2025

Record last verified: 2025-12