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

Primary Purpose

Brain and Central Nervous System Tumors, Kidney Cancer, Leukemia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nutritional intervention
therapeutic nutritional supplementation
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Correlative/Supportive Care

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    February 27, 2008
    Last Updated
    December 10, 2014
    Sponsor
    Vanderbilt University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00624962
    Brief Title
    Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors
    Official Title
    Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no participants enrolled
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    January 2008 (Anticipated)
    Study Completion Date
    January 2008 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain and Central Nervous System Tumors, Kidney Cancer, Leukemia, Liver Cancer, Neuroblastoma, Sarcoma, Solid Tumor
    Keywords
    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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Correlative/Supportive Care
    Arm Type
    Other
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    nutritional intervention
    Other Intervention Name(s)
    Non indicated
    Intervention Description
    Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    therapeutic nutritional supplementation
    Other Intervention Name(s)
    not indicated
    Intervention Description
    enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period
    Time Frame
    twelve weeks
    Title
    Number of times tubes replaced and number of subjects refusing replacement
    Title
    Grade 3/4 gastrointestinal toxicity associated with enteral support
    Title
    Complications associated with tube placement
    Title
    Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level
    Time Frame
    Not indicated
    Title
    Days of enteral (tube feeding) and total parenteral nutrition
    Title
    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
    Title
    Duration of hospitalization
    Title
    Need for post-discharge nutritional support

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John B. Pietsch, MD
    Organizational Affiliation
    Vanderbilt-Ingram Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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