Nutritional StatusNCT07264023
Correlation Between Nutritional Status of Childhood Neurological Tumors and Quality of Life
An observational study of Nutritional Status and Quality of Life, run by Nanfang Hospital, Southern Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Nutritional Status, Quality of Life, Children
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with neuro-oncological tumors
Who may be able to join
- 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.
Who cannot join
- Accompanied by other serious complications;
- The researcher judged that it was not suitable to participate in this study.
About this study
Official title: 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.
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.
- Conditions
- Nutritional Status, Quality of Life, Children, Brain Tumor, Primary
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before radiotherapy, at the end of radiotherapy, one month after radiotherapy, three months after radiotherapy, six months after radiotherapy
nutritional status
Measured: Before radiotherapy, at the end of radiotherapy, one month after radiotherapy, three months after radiotherapy, and six months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264023
- Sponsor's protocol ID
- NFEC-2025-582
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07264023
- Acronym / sponsor ID
- NFEC-2025-582
- Conditions
- Nutritional Status, Quality of Life, Children, Brain Tumor, Primary
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with neuro-oncological tumors
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Accompanied by other serious complications;
- The researcher judged that it was not suitable to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
life quality
Time frame: 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
Time frame: Before radiotherapy, at the end of radiotherapy, one month after radiotherapy, three months after radiotherapy, and six months after radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Related trials for Nutritional Status
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status and Quality of Life, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
life quality (time frame: Before radiotherapy, at the end of radiotherapy, one month after radiotherapy, three months after radiotherapy, six months after radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.