Pediatric Oncology Nutrition Intervention Trial

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

January 31, 2024

Primary Completion Date

August 4, 2025

Study Completion Date

August 4, 2025

Conditions
Pediatric CancerNutrition Related CancerNutrition Aspect of CancerMuscle LossMalnutrition, Child
Interventions
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

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

Trial Locations (1)

40536

University of Kentucky, Lexington

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

lead

Corey Hawes

OTHER

NCT06175273 - Pediatric Oncology Nutrition Intervention Trial | Biotech Hunter | Biotech Hunter