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

December 10, 2014 updated by: John B. Pietsch, Vanderbilt University

Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Correlative/Supportive Care
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)
Other Names:
  • Non indicated
Dietary supplement: therapeutic nutritional supplementation
enteral feedings via a nasogastric tube for 50% or more of the total nutritional support days.
Other Names:
  • not indicated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
50% or more of the total nutritional support days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of hospitalization
Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period
Time Frame: twelve weeks
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
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
week 12 or beginning course of Chemotherapy
Need for post-discharge nutritional support

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John B. Pietsch, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ANTICIPATED)

January 1, 2008

Study Completion (ANTICIPATED)

January 1, 2008

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (ESTIMATE)

February 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000583517
  • VU-VICC-PED-0604
  • VU-VICC-060151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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