Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors

NCT00624962 | Withdrawn DMC

• 3 other identifiers: CDR0000583517VU-VICC-PED-0604VU-VICC-060151
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain and Central Nervous System Tumors; Kidney Cancer; Leukemia; Liver Cancer; Neuroblastoma; Sarcoma; Solid Tumor

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

Study Arms (1)

Correlative/Supportive Care

OTHER

Dietary Supplement: nutritional intervention; Dietary Supplement: therapeutic nutritional supplementation

Interventions

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)

Also known as: Non indicated

Correlative/Supportive Care

therapeutic nutritional supplementation DIETARY_SUPPLEMENT

enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.

Also known as: not indicated

Correlative/Supportive Care

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Central Nervous System Neoplasms; Kidney Neoplasms; Leukemia; Liver Neoplasms; Neuroblastoma; Sarcoma; Hepatoblastoma; Familial ependymoma; Meningioma; Wilms Tumor; Medulloblastoma

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms, Complex and Mixed; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glioma

Study Officials

• John B. Pietsch, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Surgery and Pediatrics

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: February 28, 2008
• Study Start: March 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 11, 2014

Record last verified: 2010-11