Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Brain and Central Nervous System Tumors
- Sponsor
- Vanderbilt University
- Primary Endpoint
- Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
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.
Investigators
John B. Pietsch
Associate Professor of Pediatric Surgery and Pediatrics
Vanderbilt University
Eligibility Criteria
Inclusion Criteria
- •Newly confirmed diagnosis of 1 of the following:
- •Acute myeloid leukemia
- •Myelodysplastic syndromes
- •Any other stage IV solid tumor including:
- •Neuroblastoma
- •Hepatoblastoma
- •Any primary cancer of the central nervous system including:
- •Cerebellar astrocytoma
- •Medulloblastoma
- •Ependymoma
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
Outcomes
Primary Outcomes
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 Outcomes
- Number of times tubes replaced and number of subjects refusing replacement
- Duration of hospitalization
- Need for post-discharge nutritional support
- Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period(twelve weeks)
- Grade 3/4 gastrointestinal toxicity associated with enteral support
- Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level(Not indicated)
- Complications associated with tube placement
- 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)
- Days of enteral (tube feeding) and total parenteral nutrition