Standardized Nutritional Management of Pediatric Patients With Solid Tumors

NCT06730204 | Recruiting DMC

• 1 other identifier: (2023)136
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tumor, Solid; Children; Nutritional Intervention

Outcome Measures

Primary Outcomes (3)

• Weight for age Z score

  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

  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

  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 Outcomes (5)

• dietary intake

  1, 2, 3, 6, 12, 18, and 24 months after enrollment

• serum albumin

  1, 2, 3, 6, 12, 18, and 24 months after enrollment

• serum prealbumin

  1, 2, 3, 6, 12, 18, and 24 months after enrollment

• hemoglobin

  1, 2, 3, 6, 12, 18, and 24 months after enrollment

• electrolytes

  1, 2, 3, 6, 12, 18, and 24 months after enrollment

Other Outcomes (4)

• fecal intestinal flora

  3 months after enrollment

• Endotoxin

  3 months after enrollment

• Diamine oxidase

  3 months after enrollment

Study Arms (2)

Standardized nutrition management（+ short peptide ONS) Group

EXPERIMENTAL

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; Dietary Supplement: Standardized nutritional management + short peptide ONS

Control group

NO INTERVENTION

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).

Interventions

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: 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

Standardized nutrition management（+ short peptide ONS) Group

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 nutrition management（+ short peptide ONS) Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Related Publications (13)

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  PMID: 25441588 RESULT

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  PMID: 22535923 RESULT

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  PMID: 19682776 RESULT

• Mohamed Elfadil O, Steien DB, Narasimhan R, Velapati SR, Epp L, Patel I, Patel J, Hurt RT, Mundi MS. Transition to peptide-based diet improved enteral nutrition tolerance and decreased healthcare utilization in pediatric home enteral nutrition. JPEN J Parenter Enteral Nutr. 2022 Mar;46(3):626-634. doi: 10.1002/jpen.2202. Epub 2021 Jul 19.

  PMID: 34145597 RESULT

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  PMID: 30896609 RESULT

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  PMID: 25752883 RESULT

• Becker P, Carney LN, Corkins MR, Monczka J, Smith E, Smith SE, Spear BA, White JV; Academy of Nutrition and Dietetics; American Society for Parenteral and Enteral Nutrition. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: indicators recommended for the identification and documentation of pediatric malnutrition (undernutrition). Nutr Clin Pract. 2015 Feb;30(1):147-61. doi: 10.1177/0884533614557642. Epub 2014 Nov 24.

  PMID: 25422273 RESULT

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  PMID: 34490992 RESULT

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  PMID: 26853397 RESULT

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Tian Qian, PhD

CONTACT

021-64931913; drqiantian@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: December 12, 2024
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (1)