Hematopoietic Stem Cell TransplantationPhase 3NCT00115258
Nutrition Support in Pediatric Stem Cell Transplantation
A Phase 3 study testing parenteral nutrition titrated to measured REE in people with Hematopoietic Stem Cell Transplantation, run by Boston Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- parenteral nutrition titrated to measured REE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: Nutrition Support in Pediatric Stem Cell Transplantation - A Randomized, Controlled Trial
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.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- parenteral nutrition titrated to measured REE
- Keywords
- Nutrition, Parenteral, Body Composition, Energy Expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parenteral nutrition titrated to measured REEOther
| Study group | Role | What they receive |
|---|---|---|
| parenteral nutrition titrated to measured REE | Experimental | parenteral nutrition titrated to measured REE Receives: Other: parenteral nutrition titrated to measured REE |
| standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in % body fat at baseline, day +30, and day +100.
Measured: day 30
Secondary outcomes (7)
Body composition measured by DXA, BIA, and 4-site skinfolds.
Measured: baseline, day 30, and day 100
Changes in body composition from baseline to day +100.
Measured: day 100
Insulin resistance, defined by HOMA, at each time point.
Measured: baseline, day 30, and day 100
Measured resting energy expenditure (REE) at each time point.
Measured: baseline, day 30, and day 100
Changes in percent predicted REE between the two groups.
Measured: baseline, day 30, and day 100
Correlation between body composition and measured REE.
Measured: baseline, day 30, and day 100
Resumption of oral intake.
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2005 (estimated)
- Study startJan 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Duggan, Boston Children's Hospital
- Investigators
- Christopher P. Duggan, M.D., M.P.H., Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115258
- Sponsor's protocol ID
- 86483
- Other IDs
- 03-11-192
- Status last verified
- Feb 2013
- First submitted
- 21 Jun 2005
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12816778Bechard 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.
PubMed 20004739Sharma 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.
PubMed 22205317
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Support in Pediatric Stem Cell Transplantation - A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00115258
- Acronym / sponsor ID
- 86483
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Nutrition, Parenteral, Body Composition, Energy Expenditure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parenteral nutrition titrated to measured REE | Experimental | Other: parenteral nutrition titrated to measured REEparenteral nutrition titrated to measured REE |
| standard of care | No intervention | – |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parenteral nutrition titrated to measured REE | Other | parenteral nutrition titrated to measured REE |
Primary outcome
Changes in % body fat at baseline, day +30, and day +100.
Time frame: day 30
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
- Background: PubMed 12816778Duggan 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.
- Background: PubMed 20004739Bechard 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.
- Results publication: PubMed 22205317Sharma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher P. Duggan, M.D., M.P.H. principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing parenteral nutrition titrated to measured REE in people with Hematopoietic Stem Cell Transplantation, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in % body fat at baseline, day +30, and day +100. (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00115258, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.