Trials / Withdrawn
WithdrawnNCT00624962
Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors
Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Vanderbilt University · Academic / Other
- Sex
- All
- Age
- 1 Year – 21 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Brain and Central Nervous System Tumors
- Kidney Cancer
- Leukemia
- Liver Cancer
- Neuroblastoma
- Sarcoma
- Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | nutritional intervention | Nutritional status assessment on enrollment in study, beginning of course 1 and end of study period (week 12 or beginning of Course 5 chemotherapy) |
| DIETARY_SUPPLEMENT | therapeutic nutritional supplementation | enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days. |
Timeline
- Start date
- 2006-03-01
- Primary completion
- 2008-01-01
- Completion
- 2008-01-01
- First posted
- 2008-02-28
- Last updated
- 2014-12-11
Source: ClinicalTrials.gov record NCT00624962. Inclusion in this directory is not an endorsement.