Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors

Vanderbilt University

Status

Withdrawn

Conditions

Solid Tumor

Sarcoma

Neuroblastoma

Brain and Central Nervous System Tumors

Kidney Cancer

Leukemia

Liver Cancer

Treatments

Dietary Supplement: therapeutic nutritional supplementation

Dietary Supplement: nutritional intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00624962

CDR0000583517

VU-VICC-060151

VU-VICC-PED-0604

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

1 to 21 years old

Volunteers

No Healthy Volunteers

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 following:
- Gastrointestinal tract dysfunction (i.e., ileus, peritonitis, obstruction)
- Active sinusitis (can be waived for patients with gastrostomy tubes)
- Obstructive tumor in the nasopharynx

PRIOR CONCURRENT THERAPY:

No prior hematopoietic stem cell transplant
All clinically indicated medications are permitted during the course of the study
No other concurrent nutritional supplements