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Trial registered on ANZCTR


Registration number
ACTRN12615000284561
Ethics application status
Approved
Date submitted
27/02/2015
Date registered
26/03/2015
Date last updated
2/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized comparison of early enteral nutrition and standard care post allogeneic stem cell transplantation.
Scientific title
Tolerability of early enteral feeding during allogeneic haematopoietic progenitor cell transplantation: a randomized comparison with ‘standard’ parenteral nutritional support.
Secondary ID [1] 286284 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
haematological malignancies 294363 0
Condition category
Condition code
Diet and Nutrition 294678 294678 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess tolerability of enteral feeding versus standard care (parenteral feeding) when commenced the day after transplantation, before the onset of gastrointestinal toxicity. Patients will be randomised on admission to early enteral nutrition or standard care. The patients receiving enteral nutrition will have a fine bore nasogastric tube inserted the day after transplantation. Supplementary enteral feeding will commence immediately at 30ml/hr continuously to allow oral intake to continue ad libitum during the day. If oral intake declines enteral feeding rates will be adjusted until patients are meeting their goal nutrition requirement.

If patients are intolerant of enteral feeding the nasogastric tube will be removed and parenteral nutrition commenced. If a low rate of enteral nutrition is tolerated but not the goal rate, top up parenteral feeding can be given.

Supplementary feeding (enteral, parenteral or combination of both) will cease once patients are meeting 60% of nutrition requirements via oral intake post neutrophil engraftment.
Intervention code [1] 291310 0
Treatment: Other
Comparator / control treatment
Patients randomised to standard care will commence parenteral feeding as per the usual protocol when oral intake is less than 60% of nutrition requirements for three days and is unlikely to improve for another week. The rate of feeding will be increased daily until meeting their goal nutrition requirements.
Control group
Active

Outcomes
Primary outcome [1] 294433 0
The primary outcome is tolerability of supplemental enteral nutrition (EN) as defined by the percentage of randomized patients who do not tolerate goal enteral feeding so must either discontinue EN or commence ‘top up’ parenteral nutrition. This is assessed by regularly speaking to the patients and the treating team plus reading the patients medical record.
Timepoint [1] 294433 0
Assessed at completion of the study
Secondary outcome [1] 313291 0
Percentage of prescribed supplementary nutrition that is received in each arm. This is assessed from the patients daily fluid balance charts during their hospital admission.
Timepoint [1] 313291 0
Daily during hospital admission for transplantation
Secondary outcome [2] 313292 0
Duration of requirement for supplemental nutritional support. This will be assessed by speaking to the patients and treating team and reading the patients medical record.
Timepoint [2] 313292 0
Twice weekly during hospital admission
Secondary outcome [3] 313293 0
Oral intake during hospital admission. This will be assessed by speaking to the patients and treating team and reading the patients medical record.
Timepoint [3] 313293 0
Twice weekly during hospital admission
Secondary outcome [4] 313294 0
Incidence of elevation of liver enzymes during supplemental feeding as assessed by daily blood tests.
Timepoint [4] 313294 0
Daily during hospital admission
Secondary outcome [5] 313295 0
Incidence of post-transplant complications including infection and graft versus host disease. This is assessed from speaking to the treating team and reading the patients medical record.
Timepoint [5] 313295 0
Monitor for infections during hospital admission and for GVHD until 100 days post transplantation
Secondary outcome [6] 313296 0
length of hospital stay
Timepoint [6] 313296 0
On discharge home
Secondary outcome [7] 313297 0
Survival at day 100
Timepoint [7] 313297 0
100 days post transplantation
Secondary outcome [8] 313298 0
Composition of enteric flora in a stool sample
Timepoint [8] 313298 0
Day 30 post transplantation
Secondary outcome [9] 313483 0
Incidence of hyperglycaemia during supplemental feeding as assessed by daily blood tests.
Timepoint [9] 313483 0
Daily during hospital admission
Secondary outcome [10] 313484 0
Incidence of hypertriglyceridemia during supplemental feeding as assessed by daily blood tests.
Timepoint [10] 313484 0
Daily during hospital admission
Secondary outcome [11] 313485 0
Duration of neutropenia as assessed by daily blood tests.
Timepoint [11] 313485 0
Daily during hospital admission

Eligibility
Key inclusion criteria
Over 18 years old, no contraindications to nasogastric tube insertion, having an allogeneic transplant with cyclophosphamide and total body irradiation or fludarabine melphalan conditioning. Also must have ability to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known anatomic deformity preventing NGT insertion or undergoing a nonmyeloablative conditioning regimen (Fludarabine/ Cyclophosphamide or Fludarabine/total body irradiation).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290843 0
Charities/Societies/Foundations
Name [1] 290843 0
Royal Brisbane and Women's Hospital Foundation
Address [1] 290843 0
RBWH Foundation
Butterfield Street
Herston
QLD
4029
Country [1] 290843 0
Australia
Primary sponsor type
Individual
Name
Sarah Andersen
Address
Nutrition and Dietetics
Level 2
Dr James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 289532 0
None
Name [1] 289532 0
Address [1] 289532 0
Country [1] 289532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294578 0
Royal Brisbane and Womens Hospital Human research ethics committee
Ethics committee address [1] 294578 0
RBWH
Level 7, block 7
Butterfield Street
Herston
QLD
4029
Ethics committee country [1] 294578 0
Australia
Date submitted for ethics approval [1] 294578 0
21/11/2014
Approval date [1] 294578 0
13/01/2015
Ethics approval number [1] 294578 0
HREC/14/QRBW/530

Summary
Brief summary
Nutritional support during allogeneic stem cell transplantation is imperative to prevent malnutrition. Nutrition support can be provided via either enteral (nasogastric) or parenteral (intravenous) feeding.
Despite increased risks of infections and complications parenteral nutrition is used routinely at most
transplant units due to patient's gastrointestinal toxicity at the time feeding is required. Recently a few small studies have shown benefits with early enteral nutrition in this group, including less infections, reduced risk of complications such as graft versus host disease, earlier neutrophil engraftment and improved survival.

This study aims to assess tolerability of enteral feeding versus standard care (parenteral feeding) when commenced the day after transplantation, before the onset of gastrointestinal toxicity.

This research study will determine which is the best form of nutritional supplementation for patients undergoing
stem cell transplantation and the results will directly improve patient care as it will inform future clinical practice and lead to new clinical guideline development.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55414 0
Ms Sarah Andersen
Address 55414 0
Department of Nutrition and Dietetics
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD
4029
Country 55414 0
Australia
Phone 55414 0
+61 7 36468268
Fax 55414 0
Email 55414 0
sarah.andersen@health.qld.gov.au
Contact person for public queries
Name 55415 0
Ms Sarah Andersen
Address 55415 0
Department of Nutrition and Dietetics
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD
4029
Country 55415 0
Australia
Phone 55415 0
+61 7 36468268
Fax 55415 0
Email 55415 0
sarah.andersen@health.qld.gov.au
Contact person for scientific queries
Name 55416 0
Ms Sarah Andersen
Address 55416 0
Department of Nutrition and Dietetics
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD
4029
Country 55416 0
Australia
Phone 55416 0
+61 7 36468268
Fax 55416 0
Email 55416 0
sarah.andersen@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary