Leukemia Clinical Trial
Official title:
Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
Verified date | November 2010 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No | |
Secondary | Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period | twelve weeks | No | |
Secondary | Number of times tubes replaced and number of subjects refusing replacement | No | ||
Secondary | Grade 3/4 gastrointestinal toxicity associated with enteral support | Yes | ||
Secondary | Complications associated with tube placement | No | ||
Secondary | Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level | Not indicated | No | |
Secondary | Days of enteral (tube feeding) and total parenteral nutrition | No | ||
Secondary | 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 | No | |
Secondary | Duration of hospitalization | No | ||
Secondary | Need for post-discharge nutritional support | No |
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