Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors
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.
|Brain and Central Nervous System Tumors Kidney Cancer Leukemia Liver Cancer Neuroblastoma Sarcoma Solid Tumor||Dietary Supplement: nutritional intervention Dietary Supplement: therapeutic nutritional supplementation|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors|
- 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. ]
- Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: week 12 or beginning course of Chemotherapy ]
- Duration of hospitalization
- Need for post-discharge nutritional support
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||January 2008|
|Estimated Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Dietary Supplement: 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)
Other Name: Non indicatedDietary Supplement: therapeutic nutritional supplementation
enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
Other Name: not indicated
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624962
|Study Chair:||John B. Pietsch, MD||Vanderbilt-Ingram Cancer Center|