Pediatric Oncology Nutrition Intervention Trial

NCT06175273 | Completed Phase 2 FDA Drug

• 2 other identifiers: 89377UL1TR001998
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Nearly 60% of pediatric patients diagnosed with cancer develop malnutrition caused by a combination of disease burden, side effects of chemotherapy, and the intensity of cancer treatment. These patients are known to have an increased risk of infection, treatment-related toxicity, inferior clinical outcomes, and increased risk of mortality. Malnutrition may progress to cancer cachexia, characterized by anorexia, increased inflammation, decreased fat, and decreased muscle mass with subsequent weight loss, which is associated with decreased overall survival. The goal of the proposed research is to determine changes in body composition, weight status, and nutritional status between common nutrition interventions including oral nutrition supplements (ONS), appetite stimulants, and enteral nutrition (EN) among pediatric cancer patients. A secondary goal of this research is to utilize the findings to develop clinical nutrition guidelines for this patient population. The specific objective of the research proposed is to solve the lack of evidence to adequately treat nutritional deficits in the pediatric oncology population. Without this data, there is a lack of clinical consistency in the initiation and selection of appropriate nutrition interventions to provide a more definitive pathway of care. This study can help formulate a clinical guideline for this patient population before, during, and after treatment.

Conditions

Pediatric Cancer; Nutrition Related Cancer; Nutrition Aspect of Cancer; Muscle Loss; Malnutrition, Child

Outcome Measures

Primary Outcomes (2)

• Body Composition

  Change in body composition will be measured by ultrasound of the quadricep muscle layer thickness in millimeters.

  Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months.

• Body Composition

  Change in body composition will be measured by mid-upper arm circumference via z-scores by measuring the mid-upper arm in centimeters and comparing to CDC standards.

  Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months.

Secondary Outcomes (18)

• Intolerances to interventions

  Those randomized to a treatment group, will receive measurements at randomization and 1 & 3 months.

• Change in weight

  Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months.

• Change in BMI

  Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months.

• Biomarkers

  Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months.

• Biomarkers

  Baseline, at 3 and 6 months from baseline for control group. Those randomized will receive measurements at randomization and 1 & 3 months.

Study Arms (4)

Control

ACTIVE COMPARATOR

Standard of Care who have either weight gain, weight maintenance, or weight loss \<10%.

Other: Standard of Care

Oral Nutrition Supplements

EXPERIMENTAL

Those receiving ONS will be prescribed a standard ONS (1.0 kcal per mL) that will meet a minimum of 50% of estimated energy needs to promote weight gain but allow for continued regular dietary intakes. The ONS will be prescribed as 8oz (240mL) per dose at least once a day, but up to six times per day depending on estimated nutrient needs.

Dietary Supplement: Oral Nutrition Supplement

Enteral Nutrition

EXPERIMENTAL

Those randomized to EN will have a feeding tube placed and started on tube feeds via a designated pump for overnight feeds, meeting at least 50% of estimated energy needs to allow for continued regular dietary intakes during the day.

Dietary Supplement: Tube Feed

Appetite Stimulants

EXPERIMENTAL

Those receiving age-appropriate appetite stimulants will be provided either cyproheptadine or olanzapine. Subjects will be given cyproheptadine if they fall between the ages of 2-12 years of age and olanzapine if they are \>12 years of age or older.

Drug: Cyproheptadine; Drug: Olanzapine

Interventions

Oral Nutrition Supplement DIETARY_SUPPLEMENT

8oz (240mL) per dose at least once a day, but up to six times per day depending on estimated nutrient needs. The formula will equate to 1.0kcal/mL

Oral Nutrition Supplements

Tube Feed DIETARY_SUPPLEMENT

EN will have a feeding tube placed and started on tube feeds via a designated pump for overnight feeds, meeting at least 50% of estimated energy needs

Enteral Nutrition

Cyproheptadine DRUG

0.25mg/kg/d divided BID. May titrate by 4mg increments to a max of 12mg/day.

Appetite Stimulants

Olanzapine DRUG

2.5mg once a day (at night). May titrate by 2.5mg increments to max of 10mg/day

Appetite Stimulants

Standard of Care OTHER

Diet education on high protein, high calorie food consumption

Control

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• New diagnosis of pediatric cancer

You may not qualify if:

• Current use or history of enteral nutrition, oral supplement, or orexigenic/anorectic use.

Sponsors & Collaborators

• Corey Hawes: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Neoplasms; Muscular Atrophy; Child Nutrition Disorders

Interventions

Enteral Nutrition; Cyproheptadine; Olanzapine; Standard of Care

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Corey J Hawes, DCN, RD, CSO, CNSC, LD

  University of Kentucky, Kentucky Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Nutrition Professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 18, 2023
• Study Start: January 31, 2024
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)