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Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors

1 Year
21 Years
Not Enrolling
Brain and Central Nervous System Tumors, Kidney Cancer, Leukemia, Liver Cancer, Neuroblastoma, Sarcoma, Solid Tumor

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Trial Information

Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors



- 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.


- 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.

Inclusion Criteria:

- Newly confirmed diagnosis of 1 of the following:

- Acute myeloid leukemia

- Myelodysplastic syndromes

- Sarcoma

- Any other stage IV solid tumor including:

- Wilms

- Neuroblastoma

- Hepatoblastoma

- Any primary cancer of the central nervous system including:

- Cerebellar astrocytoma

- Medulloblastoma

- Ependymoma

- Spine tumors

Exclusion Criteria:

- No contraindication to enteral tube feeding including, but not limited to, any of the

- Gastrointestinal tract dysfunction (i.e., ileus, peritonitis, obstruction)

- Active sinusitis (can be waived for patients with gastrostomy tubes)

- Obstructive tumor in the nasopharynx


- No prior hematopoietic stem cell transplant

- All clinically indicated medications are permitted during the course of the study

- No other concurrent nutritional supplements

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days

Outcome Time Frame:

50% or more of the total nutritional support days.

Safety Issue:


Principal Investigator

John B. Pietsch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2006

Completion Date:

January 2008

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Neuroblastoma
  • Sarcoma
  • Solid Tumor
  • childhood soft tissue sarcoma
  • neuroblastoma
  • childhood hepatoblastoma
  • childhood cerebellar astrocytoma
  • childhood ependymoma
  • childhood brain stem glioma
  • childhood meningioma
  • childhood myelodysplastic syndromes
  • unspecified childhood solid tumor, protocol specific
  • childhood acute myeloid leukemia/other myeloid malignancies
  • central nervous system neoplasm
  • Wilms tumor and other childhood kidney tumors
  • childhood brain tumor
  • childhood medulloblastoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Liver Neoplasms
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms
  • Neoplasms
  • Sarcoma