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

This study has been withdrawn prior to enrollment.
(no participants enrolled)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John B. Pietsch, Vanderbilt University
ClinicalTrials.gov Identifier:
First received: February 27, 2008
Last updated: December 10, 2014
Last verified: November 2010

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.

Condition Intervention
Brain and Central Nervous System Tumors
Kidney Cancer
Liver Cancer
Solid Tumor
Dietary Supplement: nutritional intervention
Dietary Supplement: therapeutic nutritional supplementation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days [ Time Frame: 50% or more of the total nutritional support days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
  • Number of times tubes replaced and number of subjects refusing replacement [ Designated as safety issue: No ]
  • Grade 3/4 gastrointestinal toxicity associated with enteral support [ Designated as safety issue: Yes ]
  • Complications associated with tube placement [ Designated as safety issue: No ]
  • Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level [ Time Frame: Not indicated ] [ Designated as safety issue: No ]
  • Days of enteral (tube feeding) and total parenteral nutrition [ Designated as safety issue: No ]
  • Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy [ Time Frame: week 12 or beginning course of Chemotherapy ] [ Designated as safety issue: No ]
  • Duration of hospitalization [ Designated as safety issue: No ]
  • Need for post-discharge nutritional support [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2006
Estimated Study Completion Date: January 2008
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Correlative/Supportive Care Dietary Supplement: nutritional intervention
Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy)
Other Name: Non indicated
Dietary Supplement: therapeutic nutritional supplementation
enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
Other Name: not indicated

Detailed Description:



  • 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.


Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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


  • No prior hematopoietic stem cell transplant
  • All clinically indicated medications are permitted during the course of the study
  • No other concurrent nutritional supplements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624962

Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Study Chair: John B. Pietsch, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: John B. Pietsch, Associate Professor of Pediatric Surgery and Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00624962     History of Changes
Other Study ID Numbers: CDR0000583517  VU-VICC-PED-0604  VU-VICC-060151 
Study First Received: February 27, 2008
Last Updated: December 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
childhood soft tissue sarcoma
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

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral

ClinicalTrials.gov processed this record on February 11, 2016