Clinical trial NCT00624962: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days
timeFrame: 50% or more of the total nutritional support days.
Secondary outcomes:
measure: Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period
timeFrame: twelve weeks
measure: Number of times tubes replaced and number of subjects refusing replacement
measure: Grade 3/4 gastrointestinal toxicity associated with enteral support
measure: Complications associated with tube placement
measure: Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level
timeFrame: Not indicated
measure: Days of enteral (tube feeding) and total parenteral nutrition
measure: Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy
timeFrame: week 12 or beginning course of Chemotherapy
measure: Duration of hospitalization
measure: Need for post-discharge nutritional support
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: John B. Pietsch, MD
role: STUDY_CHAIR
References: