Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
OBJECTIVES:
Primary
- To determine the feasibility and acceptance of undertaking early enteral tube feedings
in children receiving induction chemotherapy for newly diagnosed acute myeloid leukemia
or myelodysplastic syndromes, primary cancers of the central nervous system, or
high-risk solid tumors.
Secondary
- To determine the safety of proactive enteral nutrition in these patients.
- To evaluate the effect of enteral nutrition on nutritional status in these patients.
OUTLINE: Patients have a small (6 or 8 French) nasogastral feeding tube or enterostomy tube
inserted after diagnosis. Peptamen® AF tube feeding is administered via the enteral tube.
Tube feedings are started as a continuous drip using an enteral feeding pump with a
subsequent steady daily rate increase. Patients receive enteral feeding during courses 1-4
of chemotherapy.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days
50% or more of the total nutritional support days.
No
John B. Pietsch, MD
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Federal Government
CDR0000583517
NCT00624962
March 2006
January 2008
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