NCT00115258

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

5.5 years

First QC Date

June 21, 2005

Last Update Submit

February 12, 2013

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Nutrition, ParenteralBody CompositionEnergy Expenditure

Outcome Measures

Primary Outcomes (1)

  • Changes in % body fat at baseline, day +30, and day +100.

    day 30

Secondary Outcomes (7)

  • Body composition measured by DXA, BIA, and 4-site skinfolds.

    baseline, day 30, and day 100

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (2)

parenteral nutrition titrated to measured REE

EXPERIMENTAL

parenteral nutrition titrated to measured REE

Other: parenteral nutrition titrated to measured REE

standard of care

NO INTERVENTION

Interventions

parenteral nutrition titrated to measured REEOTHER
parenteral nutrition titrated to measured REE

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 12816778BACKGROUND

  • 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.

    PMID: 20004739BACKGROUND

  • 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.

    PMID: 22205317RESULT

Study Officials

  • Christopher P. Duggan, M.D., M.P.H.

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of pediatrics

Study Record Dates

First Submitted

June 21, 2005

First Posted

June 22, 2005

Study Start

January 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 13, 2013

Record last verified: 2013-02