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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00624962
• Other study ID #: CDR0000583517
• Secondary ID: VU-VICC-PED-0604
• Status: Withdrawn
• Phase: N/A
• First received: February 27, 2008
• Last updated: December 10, 2014
• Start date: March 2006
• Est. completion date: January 2008

Study information

• Verified date: November 2010
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Outcome

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