Leukemia Clinical Trial
Official title:
Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger
patients receiving chemotherapy for cancer.
PURPOSE: This clinical trial is studying how well tube feedings work in younger patients
receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome,
or 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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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