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Trial registered on ANZCTR


Registration number
ACTRN12611001084976
Ethics application status
Approved
Date submitted
18/10/2011
Date registered
19/10/2011
Date last updated
19/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
What is the best form of nutrition support during an Allogeneic Transplant
Scientific title
A randomized comparison of tolerance of parenteral nutrition and enteral feeding as nutritional support during allogeneic haematopoietic progenitor cell transplantation
Secondary ID [1] 273224 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allogeneic transplants 278985 0
Nutrition support 278986 0
Condition category
Condition code
Cancer 279166 279166 0 0
Leukaemia - Acute leukaemia
Cancer 279167 279167 0 0
Leukaemia - Chronic leukaemia
Cancer 279168 279168 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who require supplementary feeding when undergoing an Allogeneic transplant will be randomised to supplemental nutritional support by parenteral nutrition (PN) versus enteral nutrition (EN) on a 1:1 basis. PN will be administered through a central venous catheter using a standard central parenteral nutrition solution including intravenous vitamin supplementation. EN will be a standard 1.25kcal/ml ready to hang formula administered through a nasogastric tube inserted at the onset of supplemental feeding. The feeding rate and goal to meet requirements will be as per the ward Dietitian. Feeding will continue until patients are able to meet 60% of requirements through oral intake for atleast one day. If a patient does not tolerate their mode of feeding they can be changed to the alternate mode of feeding at any time.
Intervention code [1] 269558 0
Treatment: Other
Comparator / control treatment
The comparator is Parenteral feeding. Parenteral feeding is standard practice at this hospital currently and this study will evaluate the tolerance of enteral versus parenteral feeding. Parenteral feeding will be administered through a central venous catheter using a standard central parenteral nutrition solution including intravenous vitamin supplementation. Feeding will continue until patients are able to meet 60% of requirements through oral intake for atleast one day or a patient does not tolerate their mode of feeding.
Control group
Active

Outcomes
Primary outcome [1] 279806 0
The primary endpoint is tolerance of route of supplemental feeding. Tolerance of route of supplemental nutritional support is defined as <30% of patients needing to change to the alternative route of support for any reason.
Timepoint [1] 279806 0
The primary outcome is measured throughout the period of supplementary feeding.
Secondary outcome [1] 294482 0
Percentage of goal nutrition delivered.
Timepoint [1] 294482 0
Data collected daily while supplementary feeding is being given
Secondary outcome [2] 294483 0
Duration of requirement for nutritional support (days)
Timepoint [2] 294483 0
At cessation of supplementary feeding
Secondary outcome [3] 294484 0
Biochemical derangements during nutritional support ie: liver function, triglyceride, blood sugar abnormalities. Impaired liver function is defined as >2 liver enzymes at or more than twice the upper limit of normal.
Timepoint [3] 294484 0
Data collected daily while supplementary feeding is being given
Secondary outcome [4] 294485 0
Duration of neutropenia. Neutrophil count is monitored daily in a blood test which is part of standard care during a transplant.
Timepoint [4] 294485 0
Before discharge from hospital
Secondary outcome [5] 294486 0
Incidence of graft versus host disease (GVHD). This will be assessed through a medical chart audit and if GVHD is diagnosed and documented by the patients Haematologist in the chart it will be recorded as an outcome.
Timepoint [5] 294486 0
At day 100 post transplant
Secondary outcome [6] 294487 0
Length of hospital stay
Timepoint [6] 294487 0
Upon patients discharge from hospital
Secondary outcome [7] 294488 0
Nutritional status using Patient generated subjective global assessment (PG-SGA)
Timepoint [7] 294488 0
On admission to hospital for transplant

Eligibility
Key inclusion criteria
Inclusion criteria include: Patients undertaking allogeneic transplants, aged >18 and <65 years and have an ability to understand and willingness to sign a written informed consent document.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: Known anatomic deformity preventing nasogastric tube insertion, non-functional and / or inaccessible gastrointestinal tract to enteral feeding when feeding is required, as defined by presence of Grade 3-4 mucositis or intestinal ileus or intractable vomiting.

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)
Patients are informed about the study by a transplant coordinator pre admission and are consented to the study by their haematologist in clinic pre admission. Patients are randomised to enteral or parenteral feeding by a computer generated randomisation list if they require supplementary feeding. The primary investigator contacts another member of the research team to randomise the patient to a type of feeding when it is required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)

Funding & Sponsors
Funding source category [1] 270052 0
Hospital
Name [1] 270052 0
Royal Brisbane and Womens Hospital Foundation
Address [1] 270052 0
Royal Brisbane and Womens Hospital, Butterfield Street, Herston, QLD 4029
Country [1] 270052 0
Australia
Primary sponsor type
Individual
Name
A/Prof Glen Kennedy
Address
Department of Clinical Haematology, Royal Brisbane and Womens Hospital, Level 5, Joyce Tweddell Building, Butterfield Street, Herston, QLD 4029
Country
Australia
Secondary sponsor category [1] 269021 0
Individual
Name [1] 269021 0
Dr Merrilyn Banks
Address [1] 269021 0
Nutrition and Dietetics, Level 2, Dr James Mayne Building, Royal Brisbane and Womens Hospital, Butterfield Street, Herston, QLD 4029
Country [1] 269021 0
Australia
Other collaborator category [1] 252302 0
Individual
Name [1] 252302 0
Sarah Cohen
Address [1] 252302 0
Nutrition and Dietetics, Level 2, Dr James Mayne Building, Royal Brisbane and Womens Hospital, Butterfield Street, Herston, QLD 4029
Country [1] 252302 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272011 0
The Royal Brisbane and Womens Hospital Human Research Ethics committee.
Ethics committee address [1] 272011 0
Butterfield Street
Herston, QLD
4029
Ethics committee country [1] 272011 0
Australia
Date submitted for ethics approval [1] 272011 0
Approval date [1] 272011 0
14/03/2011
Ethics approval number [1] 272011 0

Summary
Brief summary
Patients undergoing a Stem Cell Transplant (SCT) often have difficulty eating adequately due to the side effects of treatment and malnutrition can occur which is associated with poor outcomes post transplant. The best type of nutrition support to be given during a SCT is controversial and Parenteral Nutrition/ Intravenous feeding (PN) is usually given over Enteral Nutrition/ Nasogastric feeding (EN) despite the increased cost, infection risks and other complications associated with PN. This project aims to determine whether PN or EN is better tolerated by SCT patients who are unable to eat adequately. If EN is successfully tolerated this will eliminate the risks, complications and cost associated with routine use of PN. This research will directly improve future patient care and will result in changes to current nutrition support practices and lead to improved outcomes for cancer transplant patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33277 0
Address 33277 0
Country 33277 0
Phone 33277 0
Fax 33277 0
Email 33277 0
Contact person for public queries
Name 16524 0
Sarah Cohen
Address 16524 0
Nutrition and Dietetics, Royal Brisbane and Women’s Hospital, Level 2, Dr James Mayne Building, Butterfield Street, Herston, QLD, 4029
Country 16524 0
Australia
Phone 16524 0
+61736367997
Fax 16524 0
Email 16524 0
sarah_cohen@health.qld.gov.au
Contact person for scientific queries
Name 7452 0
Sarah Cohen
Address 7452 0
Nutrition and Dietetics, Royal Brisbane and Women’s Hospital, Level 2, Dr James Mayne Building, Butterfield Street, Herston, QLD, 4029
Country 7452 0
Australia
Phone 7452 0
+61736367997
Fax 7452 0
Email 7452 0
sarah_cohen@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results