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Nutrition Support in Pediatric Stem Cell Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Duggan, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00115258
First received: June 21, 2005
Last updated: February 12, 2013
Last verified: February 2013
  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: Double Blind (Subject, Caregiver, 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 Children's Hospital Boston:

Primary Outcome Measures:
  • Changes in % body fat at baseline, day +30, and day +100. [ Time Frame: day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition measured by DXA, BIA, and 4-site skinfolds. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
  • Changes in body composition from baseline to day +100. [ Time Frame: day 100 ] [ Designated as safety issue: No ]
  • Insulin resistance, defined by HOMA, at each time point. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
  • Measured resting energy expenditure (REE) at each time point. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
  • Changes in percent predicted REE between the two groups. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
  • Correlation between body composition and measured REE. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
  • Resumption of oral intake. [ Time Frame: day 30 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115258

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