Tube Feedings in Younger Patients Receiving Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia, Myelodysplastic Syndromes, or High-Risk Solid Tumors - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00624962

Purpose

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
Brain and Central Nervous System Tumors Kidney Cancer Leukemia Liver Cancer Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific	Dietary Supplement: nutritional intervention Dietary Supplement: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Liver Cancer Neuroblastoma Nutritional Support Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period [ Designated as safety issue: No ]
Number of times tubes replaced and number of subjects refusing replacement [ Designated as safety issue: No ]
Grade 3/4 gastrointestinal toxicity associated with enteral support [ Designated as safety issue: Yes ]
Complications associated with tube placement [ Designated as safety issue: No ]
Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level [ Designated as safety issue: No ]
Days of enteral (tube feeding) and total parenteral nutrition [ Designated as safety issue: No ]
Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy [ Designated as safety issue: No ]
Duration of hospitalization [ Designated as safety issue: No ]
Need for post-discharge nutritional support [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	March 2006
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	1 Year to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624962

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

John B. Pietsch, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000583517, VU-VICC-PED-0604, VU-VICC-060151
Study First Received:	February 27, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00624962 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Liver Diseases
Neuroectodermal Tumors, Primitive
Urogenital Neoplasms
Central Nervous System Neoplasms
Urologic Neoplasms
Neoplasms, Connective and Soft Tissue
Preleukemia
Acute Myelocytic Leukemia
Wilms' Tumor
Neuroepithelioma
Hepatoblastoma
Glioma
Kidney Diseases
Nervous System Neoplasms
Digestive System Neoplasms

Astrocytoma
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid
Carcinoma
Brain Neoplasms
Neuroectodermal Tumors
Malignant Mesenchymal Tumor
Brain Stem Glioma, Childhood
Sarcoma
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial
Urinary Tract Neoplasm
Precancerous Conditions
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:

Liver Diseases
Neuroectodermal Tumors, Primitive
Precancerous Conditions
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Central Nervous System Neoplasms
Leukemia, Myeloid, Acute
Urologic Neoplasms
Neuroblastoma
Liver Neoplasms
Neoplasms, Connective and Soft Tissue
Leukemia
Preleukemia
Neoplasms by Site
Urologic Diseases

Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Kidney Diseases
Nervous System Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Hematologic Diseases
Nervous System Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Carcinoma
Neuroectodermal Tumors
Neoplasms
Digestive System Diseases
Sarcoma

ClinicalTrials.gov processed this record on September 04, 2009