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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00624962 |
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.
Condition | Intervention |
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Brain and Central Nervous System Tumors Kidney Cancer Leukemia Liver Cancer Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Procedure: nutritional intervention Procedure: therapeutic nutritional supplementation |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors |
Estimated Enrollment: | 16 |
Study Start Date: | March 2006 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly confirmed diagnosis of 1 of the following:
Any other stage IV solid tumor including:
Any primary cancer of the central nervous system including:
PATIENT CHARACTERISTICS:
No contraindication to enteral tube feeding including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 |
Study Chair: | John B. Pietsch, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000583517, VU-VICC-PED-0604, VU-VICC-060151 |
Study First Received: | February 27, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00624962 |
Health Authority: | United States: Federal Government |
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 |
Liver Diseases Neuroectodermal Tumors, Primitive Malignant mesenchymal tumor Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Neoplasms, Connective and Soft Tissue Preleukemia Neuroepithelioma Hepatoblastoma Glioma Kidney Diseases Nervous System Neoplasms Myelodysplastic syndromes Digestive System Neoplasms |
Astrocytoma Hematologic Diseases Myeloproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Renal cancer Carcinoma Brain Neoplasms Neuroectodermal Tumors Sarcoma Gastrointestinal Neoplasms Neoplasms, Glandular and Epithelial Precancerous Conditions Liver neoplasms Leukemia, Myeloid, Acute |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Neoplasms, Nerve Tissue Nervous System Diseases Neoplasms, Neuroepithelial |