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

Vanderbilt University

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

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

Interventions

nutritional interventionDIETARY_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)

therapeutic nutritional supplementationDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 50% or more of the total nutritional support days.

Secondary Outcomes

Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period

Time frame: 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

Time frame: Not indicated

Days of enteral (tube feeding) and total parenteral nutrition

Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy

Time frame: week 12 or beginning course of Chemotherapy

Duration of hospitalization

Need for post-discharge nutritional support

Data from ClinicalTrials.gov

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