Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors
NCT ID: NCT00624962
Last Updated: 2014-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2006-03-31
2008-01-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Correlative/Supportive Care
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)
therapeutic nutritional supplementation
enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
Interventions
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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)
therapeutic nutritional supplementation
enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt University
OTHER
Responsible Party
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John B. Pietsch
Associate Professor of Pediatric Surgery and Pediatrics
Principal Investigators
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John B. Pietsch, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Countries
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Other Identifiers
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VU-VICC-PED-0604
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-060151
Identifier Type: -
Identifier Source: secondary_id
CDR0000583517
Identifier Type: -
Identifier Source: org_study_id