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NCT Number: NCT06730204

Standardized Nutritional Management of Pediatric Patients With Solid Tumors

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.

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Key information

Conditions

Tumor, Solid Children Neoplasms Nutritional Intervention

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

Tian Qian, PhD

CONTACT

[email protected]

021-64931913

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized nutritional management

Dietary Supplement

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.

Standardized nutritional management + short peptide ONS

Dietary Supplement

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:

  • Male and female, age 1-10 years old
  • Pathological diagnosis is malignant solid tumor with untreated initial onset
  • It is expected to receive enteral nutrition intervention for 3 months
  • Clear consciousness, willing to cooperate, no serious dysfunction of major organ functions

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tian Qian, PhD

CONTACT

[email protected]

021-64931913

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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