Text Size

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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00624962
First received: February 27, 2008
Last updated: November 29, 2010
Last verified: November 2010
History of Changes
  Purpose

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
Leukemia
Liver Cancer
Neuroblastoma
Sarcoma
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:

U.S. FDA Resources

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 [ Time Frame: not specified ] [ Designated as safety issue: No ]
  • Grade 3/4 gastrointestinal toxicity associated with enteral support [ Time Frame: Not specified ] [ Designated as safety issue: Yes ]
  • Complications associated with tube placement [ Time Frame: Not specified ] [ 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 [ Time Frame: Not specified ] [ 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 [ Time Frame: Not specified ] [ Designated as safety issue: No ]
  • Need for post-discharge nutritional support [ Time Frame: Not specified ] [ 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:

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.

  Eligibility

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

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

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

No publications provided

Responsible Party: John Pietsch, Vanderbilt-Ingram Cancer Center
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: November 29, 2010
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Leukemia
Liver Neoplasms
Nervous System Neoplasms
Neuroblastoma
Central Nervous System Neoplasms
Neoplasms
Sarcoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Kidney Diseases
Urologic Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on May 21, 2013