Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Tube Feedings in Younger Patients Receiving Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia, Myelodysplastic Syndromes, or High-Risk Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Completed 1 to 21 NCI VU-VICC-PED-0604 VICC PED0604, VU-VICC-060151, NCT00624962

Objectives

Primary

1. 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

1. To determine the safety of proactive enteral nutrition in these patients.
2. To evaluate the effect of enteral nutrition on nutritional status in these patients.

Entry Criteria

Disease Characteristics:

• 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

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

Patient Characteristics:

• 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

Expected Enrollment

Outcomes

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

Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period
Number of times tubes replaced and number of subjects refusing replacement
Grade 3/4 gastrointestinal toxicity associated with enteral support
Complications associated with tube placement
Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level
Days of enteral (tube feeding) and total parenteral nutrition
Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy
Duration of hospitalization
Need for post-discharge nutritional support

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.

Trial Contact Information

Trial Lead Organizations

Vanderbilt-Ingram Cancer Center

John Pietsch, MD, Protocol chair		Ph: 615-936-1050; 800-811-8480

Registry Information
Official Title		Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
Trial Start Date		2006-03-29
Trial Completion Date		2008-04-18
Registered in ClinicalTrials.gov		NCT00624962
Date Submitted to PDQ		2008-01-07
Information Last Verified		2008-10-01
NCI Grant/Contract Number		CA68485

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