Clinical trial NCT00115258: Nutrition Support in Pediatric Stem Cell Transplantation
Official title: Nutrition Support in Pediatric Stem Cell Transplantation - A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Nutrition, Parenteral
Body Composition
Energy Expenditure
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2005-06-22
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Changes in % body fat at baseline, day +30, and day +100.
timeFrame: day 30
Secondary outcomes:
measure: Body composition measured by DXA, BIA, and 4-site skinfolds.
timeFrame: baseline, day 30, and day 100
measure: Changes in body composition from baseline to day +100.
timeFrame: day 100
measure: Insulin resistance, defined by HOMA, at each time point.
timeFrame: baseline, day 30, and day 100
measure: Measured resting energy expenditure (REE) at each time point.
timeFrame: baseline, day 30, and day 100
measure: Changes in percent predicted REE between the two groups.
timeFrame: baseline, day 30, and day 100
measure: Correlation between body composition and measured REE.
timeFrame: baseline, day 30, and day 100
measure: Resumption of oral intake.
timeFrame: day 30
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Christopher P. Duggan, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duggan C, Bechard L, Donovan K, Vangel M, O'Leary A, Holmes C, Lehmann L, Guinan E. Changes in resting energy expenditure among children undergoing allogeneic stem cell transplantation. Am J Clin Nutr. 2003 Jul;78(1):104-9. doi: 10.1093/ajcn/78.1.104.
citation: Bechard LJ, Feldman HA, Gordon C, Gura K, Sonis A, Leung K, Venick R, Guinan EC, Duggan C. A multi-center, randomized, controlled trial of parenteral nutrition titrated to resting energy expenditure in children undergoing hematopoietic stem cell transplantation ("PNTREE"): rationale and design. Contemp Clin Trials. 2010 Mar;31(2):157-64. doi: 10.1016/j.cct.2009.12.002. Epub 2010 Jan 3.
citation: Sharma TS, Bechard LJ, Feldman HA, Venick R, Gura K, Gordon CM, Sonis A, Guinan EC, Duggan C. Effect of titrated parenteral nutrition on body composition after allogeneic hematopoietic stem cell transplantation in children: a double-blind, randomized, multicenter trial. Am J Clin Nutr. 2012 Feb;95(2):342-51. doi: 10.3945/ajcn.111.026005. Epub 2011 Dec 28.