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Nutrition Support in Pediatric Stem Cell Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115258
First Posted: June 22, 2005
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Duggan, Children's Hospital Boston
  Purpose
The purpose of this study is to determine which method of providing parenteral nutrition (complete intravenous nutrition) will provide the best nutritional and clinical results to children undergoing hematopoietic stem cell transplantation.

Condition Intervention Phase
Hematopoietic Stem Cell Transplantation Other: parenteral nutrition titrated to measured REE Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutrition Support in Pediatric Stem Cell Transplantation - A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Christopher Duggan, Children's Hospital Boston:

Primary Outcome Measures:
  • Changes in % body fat at baseline, day +30, and day +100. [ Time Frame: day 30 ]

Secondary Outcome Measures:
  • Body composition measured by DXA, BIA, and 4-site skinfolds. [ Time Frame: baseline, day 30, and day 100 ]
  • Changes in body composition from baseline to day +100. [ Time Frame: day 100 ]
  • Insulin resistance, defined by HOMA, at each time point. [ Time Frame: baseline, day 30, and day 100 ]
  • Measured resting energy expenditure (REE) at each time point. [ Time Frame: baseline, day 30, and day 100 ]
  • Changes in percent predicted REE between the two groups. [ Time Frame: baseline, day 30, and day 100 ]
  • Correlation between body composition and measured REE. [ Time Frame: baseline, day 30, and day 100 ]
  • Resumption of oral intake. [ Time Frame: day 30 ]

Enrollment: 26
Study Start Date: January 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: parenteral nutrition titrated to measured REE
parenteral nutrition titrated to measured REE
Other: parenteral nutrition titrated to measured REE
No Intervention: standard of care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First myeloablative allogeneic SCT using either TBI (1400 cGy) or busulfan in addition to other chemotherapeutic agents
  • GVHD prophylaxis with a calcineurin-inhibitor and methotrexate +/- corticosteroids
  • Matched, related or 6/6 HLA-matched unrelated SCT donor
  • Age 6 years and older

Exclusion Criteria:

  • Age less than 6 years, or otherwise unable to comply with study procedures
  • Underweight (body mass index (BMI) z-score <2 for age and sex) at baseline
  • Overweight (BMI z-score >2 for age and sex) at baseline
  • Unable or unwilling to return for day + 100 studies
  • Previous stem cell transplant
  • Unmatched SCT donor
  • Current treatment for hypo- or hyperthyroidism
  • Current insulin dependent diabetes
  • Current use of parenteral nutrition
  • Allergy to egg or soy products
  • Other contraindication to parenteral nutrition at baseline
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115258


Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Christopher P. Duggan, M.D., M.P.H. Boston Children’s Hospital