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| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-PED-0604 | |||
| VU-VICC-060151 |
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no participants enrolled
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Correlative/Supportive Care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional intervention | Dietary Supplement | Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy) |
| 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. |
| 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 |
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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:
Any primary cancer of the central nervous system including:
Exclusion Criteria:
No contraindication to enteral tube feeding including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| John B. Pietsch, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
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| therapeutic nutritional supplementation | Dietary Supplement | enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days. |
|
|
| 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 |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008113 | Liver Neoplasms |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| D018197 | Hepatoblastoma |
| C531673 | Familial ependymoma |
| D008579 | Meningioma |
| D009396 | Wilms Tumor |
| D008527 | Medulloblastoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005910 | Glioma |
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