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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain and Central Nervous System Tumors, Kidney Cancer, Leukemia, Liver Cancer, Neuroblastoma, Sarcoma, Solid Tumor

Intervention / Treatment
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* Dietary Supplement: nutritional intervention
* Dietary Supplement: therapeutic nutritional supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Correlative/Supportive Care<br> | Dietary Supplement: nutritional intervention<br>* Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy)<br>* Other names: Non indicated;Dietary Supplement: therapeutic nutritional supplementation<br>* enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.<br>* Other names: not indicated;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days |  | 50% or more of the total nutritional support days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period |  | 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 |  | 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 |  | week 12 or beginning course of Chemotherapy | 
| Duration of hospitalization |  |  | 
| Need for post-discharge nutritional support |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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