Brain and Central Nervous System Tumors, Kidney Cancer, Leukemia, Liver Cancer, Neuroblastoma, Sarcoma, Solid Tumor
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTnutritional 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)
DIETARY_SUPPLEMENTtherapeutic nutritional supplementation
enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
Sponsors
National Cancer Institute (NCI)
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period | twelve weeks |
| 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 | — |
| Days of enteral (tube feeding) and total parenteral nutrition | — |
Outcome results
None listed