Standardized Nutritional Management of Pediatric Patients With Solid Tumors

March 13, 2026 updated by: Children's Hospital of Fudan University

Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study

The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors.

After admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. Basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201102
        • Recruiting
        • Children's Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

  1. Male and female, age 0-18 years old
  2. Pathological diagnosis is malignant solid tumor with untreated initial onset

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standardized nutrition management（+ short peptide ONS) Group

The children in this group will be given standardized nutrition management after admission. They will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected.

During the study period, an additional 3 months of short peptide oral nutritional supplements (ONS) is expected to be performed in children enrolled from December 1, 2024 to February 28, 2025 to explore the improvement of the nutritional status of the children.
Dietary supplement: Standardized nutritional management
The children will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the target amount cannot be reached for 3-5 days, the upper step of the treatment can be selected.
Dietary supplement: Standardized nutritional management + short peptide ONS

During the study period, an additional 3 months of short peptide ONS enteral nutrition intervention is expected to be performed in children enrolled from Dec 1, 2024 to Feb 28, 2025 to explore the improvement of the nutritional status of the children. Short peptide type ONS 30ml/(kg.d) will be taken orally for children under 3 years old, and 20ml/(kg.d) for children over 3 years old. Due to conditional restrictions, standardized nutritional management + short peptide ONS intervention is only carried out in this subgroup.

Inclusion criteria for short peptide ONS enteral nutrition intervention:

  1. Male and female, age 1-10 years old
  2. Pathological diagnosis is malignant solid tumor with untreated initial onset
  3. It is expected to receive enteral nutrition intervention for 3 months
  4. Clear consciousness, willing to cooperate, no serious dysfunction of major organ functions
No Intervention: Control group
Clinical variables, biochemical markers, dietary data, and physical activity data will be collected at baseline and at each visit (admission to hospital, 1, 2, 3, 6, 12, 18, and 24 months after diagnosis).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight for age Z score
Time Frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Weight for age Z score = (Actual weight - reference population median) / reference population standard deviation
1, 2, 3, 6, 12, 18, and 24 months after enrollment
height/length for age Z score
Time Frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Height/length for age Z score = (Actual height/length - reference population median) / reference population standard deviation
1, 2, 3, 6, 12, 18, and 24 months after enrollment
BMI for age Z score
Time Frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
BMI for age Z score = (Actual BMI - reference population median) / reference population standard deviation
1, 2, 3, 6, 12, 18, and 24 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dietary intake
Time Frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Unit: kcal/d A 24-hour dietary survey record will be conducted on the children to evaluate the quantity, type and energy of the food consumed.
1, 2, 3, 6, 12, 18, and 24 months after enrollment
serum albumin
Time Frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Unit: g/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.
1, 2, 3, 6, 12, 18, and 24 months after enrollment
serum prealbumin
Time Frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Unit: mg/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.
1, 2, 3, 6, 12, 18, and 24 months after enrollment
hemoglobin
Time Frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Unit: g/L This indicator is measured by the hemocytometer XS800I in the hospital laboratory department.
1, 2, 3, 6, 12, 18, and 24 months after enrollment
electrolytes
Time Frame: 1, 2, 3, 6, 12, 18, and 24 months after enrollment
Unit: mmol/L This indicator is measured by the biochemical assembly line Remisol in the hospital laboratory department.
1, 2, 3, 6, 12, 18, and 24 months after enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
fecal intestinal flora
Time Frame: 3 months after enrollment
For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.
3 months after enrollment
Endotoxin
Time Frame: 3 months after enrollment
For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.
3 months after enrollment
Diamine oxidase
Time Frame: 3 months after enrollment
For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.
3 months after enrollment
D-lactic acid
Time Frame: 3 months after enrollment
For children with short peptide type enteral nutrition intervention, the above indicators will be collected at the time of enrollment and 3 months after enrollment.
3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (2023)136

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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