Nutrition Support in Pediatric Stem Cell Transplantation

Phase 3

Completed

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Other: parenteral nutrition titrated to measured REE

• Registration Number: NCT00115258
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-06-21
• Study First Submitted QC: 2005-06-21
• Study First Posted: 2005-06-22
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
parenteral nutrition titrated to measured REE	parenteral nutrition titrated to measured REE	parenteral nutrition titrated to measured REE

Primary Outcome Measures

Name	Time	Method
Changes in % body fat at baseline, day +30, and day +100.	day 30

Secondary Outcome Measures

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