Standardized Nutritional Management of Pediatric Patients With Solid Tumors

Fudan University

Status: Enrolling

Conditions: Nutritional Intervention; Children; Tumor, Solid

Treatments: Dietary Supplement: Standardized nutritional management; Dietary Supplement: Standardized nutritional management + short peptide ONS

Study type: Interventional

Funder types: Other

Identifiers

NCT06730204

(2023)136

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Standardized nutrition management（+ short peptide ONS) Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Standardized nutritional management + short peptide ONS

Dietary Supplement: Standardized nutritional management

Control group

No Intervention group

Description:

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).