Pediatric Oncology Nutrition Intervention Trial

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

Interventions

DRUG

Cyproheptadine

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

DRUG

Olanzapine

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

OTHER

Standard of Care

Diet education on high protein, high calorie food consumption

DIETARY_SUPPLEMENT

Oral Nutrition 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

DIETARY_SUPPLEMENT

Tube Feed

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

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Corey Hawes

  lead OTHER

Principal Investigators

• Corey J Hawes, DCN, RD, CSO, CNSC, LD · University of Kentucky, Kentucky Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-31

Primary Completion

2025-08-04

Completion

2025-08-04

FDA Drug

Yes

Countries

• United States

Study Locations