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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2008

Detailed 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.

Interventions

  • 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)
  • Dietary Supplement: therapeutic nutritional supplementation
    • enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.

Arms, Groups and Cohorts

  • Other: Correlative/Supportive Care

Clinical Trial Outcome Measures

Primary 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.

Secondary Measures

  • Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period
    • Time Frame: twelve weeks
  • 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
    • Time Frame: Not indicated
  • 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
    • Time Frame: week 12 or beginning course of Chemotherapy
  • Duration of hospitalization
  • Need for post-discharge nutritional support

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: John B. Pietsch, Associate Professor of Pediatric Surgery and Pediatrics – Vanderbilt University
  • Overall Official(s)
    • John B. Pietsch, MD, Study Chair, Vanderbilt-Ingram Cancer Center

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