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Trial registered on ANZCTR


Registration number
ACTRN12615001329550
Ethics application status
Approved
Date submitted
13/11/2015
Date registered
4/12/2015
Date last updated
1/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Prophylactic early parenteral nutrition in patients undergoing haematopoietic cell transplantation: A multi-centre randomised controlled trial..
Scientific title
Effect of supplemental prophylactic early parenteral nutrition commenced prior to chemoradiotherapy compared to pragmatic standard nutrition care on disease free survival in patients about to commence conditioning chemoradiotherapy for allogeneic haematopoietic progenitor/stem cell transplantation.
Secondary ID [1] 287876 0
NRMRC application no: APP1108301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological malignancies 296762 0
Condition category
Condition code
Diet and Nutrition 296998 296998 0 0
Other diet and nutrition disorders
Blood 296999 296999 0 0
Haematological diseases
Cancer 297049 297049 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell transplant.

A standard parenteral nutrition solution will be used. The parenteral nutrition solution will be given once daily, and infused intravenously. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L). Nutritional targets will be measured using indirect Calorimetry where available, or calculated via the Harris Benedict or Schofield equations. The dose of parenteral nutrition administered will be determined by the treating dietitian, treating physician or treating research team. The parenteral nutrition dose given will be individualised considering the patients clinical condition and body weight. The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake.
Supplemental parenteral nutrition will be discontinued when a patient is well enough to be discharged from hospital or when the patients attending clinician determines a central line is no longer needed for standard care. There is no maximum duration of supplemental parenteral nutrition..
Adherence to the study intervention will be monitored via medical chart reviews during site monitoring visits, and data queries on individual patient case report form documentation.
Intervention code [1] 293244 0
Prevention
Comparator / control treatment
The control group in this study is pragmatic standard nutrition care.
Currently after a bone marrow transplant in Australia, patients are normally fed orally for as long as possible. If oral intake fails to provide sufficient calories for a period of two to three days, enteral or parenteral nutrition may be provided.
Control group
Active

Outcomes
Primary outcome [1] 296594 0
Disease free survival time, will be defined as time to relapse or death whichever occurs first. Time to relapse will be diagnosed by standard criteria defined by the European Group for Blood and Marrow Transplantation and the Australasian Bone Marrow Transplant Recipient Registry.
Timepoint [1] 296594 0
Recruitment will run for 3 years. Patients recruited in the first year of the study will be followed for 4 years. Patients recruited in the last year of the study will receive 1 year follow-up.
Secondary outcome [1] 318837 0
Overall survival time
Timepoint [1] 318837 0
Recruitment will run for 3 years. Patients recruited in the first year of the study will be followed for 4 years. Patients recruited in the last year of the study will receive 1 year follow-up.
Secondary outcome [2] 318839 0
Health related quality of life ascertained using the SF36
Timepoint [2] 318839 0
Assessed at 100 days after study randomisation,
Secondary outcome [3] 318840 0
Infectious complications assessed using standardised definitions as per the International Sepsis Forum [1] and graded for severity as per Cohen et al [2].

1. International Sepsis Forum. Definition of Infection in the ICU Consensus Conference. The international sepsis forum consensus conference on definitions of infection in the intensive
care unit. Crit Care Med. 2005;33(7):1538- 1548.
2. Cohen J, Cristofaro P, Carlet J, Opal S. New method of classifying infections in critically ill patients. Crit Care Med. 2004;32(7):1510-1526.
Timepoint [3] 318840 0
During hospital stay of the index hospital admission.
Secondary outcome [4] 318841 0
Costs to the acute health care system assessed using a large scale Monte Carlo simulation of a stochastic cost model
Timepoint [4] 318841 0
Costed over the index hospital stay

Eligibility
Key inclusion criteria
Patients who are about to commence conditioning chemoradiotherapy for allogeneic haematopoietic progenitor/stem cell transplantation, who have a haematological malignancy, who are not meeting 80% of their Caloric needs via oral or enteral intakes, and who are not malnourished.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are already receiving parenteral nutrition at time of screening.
Patients with a documented licensing contraindication to parenteral nutrition.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained through the use of a central randomisation web site that is secure, encrypted and password protected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within each study center, randomisation will be stratified based on the risk of relapse (Standard versus High) and type of transplant conditioning (Myeloablative versus Reduced Intensity Conditioning).
Blocks of variable size and a random seed will be used to ensure allocation concealment cannot be violated by deciphering the sequence near the end of each block. To further protect against deciphering, block sizes and strata thresholds will not be revealed to site investigators.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet 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)
NSW,SA,WA,VIC
Recruitment outside Australia
Country [1] 7328 0
Italy
State/province [1] 7328 0
Rome
Country [2] 7329 0
New Zealand
State/province [2] 7329 0
Auckland

Funding & Sponsors
Funding source category [1] 292374 0
Government body
Name [1] 292374 0
National Health and Medical Research Council
Address [1] 292374 0
GPO Box 1421, Canberra, ACT, 2601.
Country [1] 292374 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Attention: Clinical Trials Office, Faculty of Medicine, K25, University of Sydney, NSW, 2006.
Country
Australia
Secondary sponsor category [1] 291062 0
None
Name [1] 291062 0
None
Address [1] 291062 0
None
Country [1] 291062 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293848 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 293848 0
Research Office, Level 13, Kolling Building, Royal North Shore Hospital, Pacific Highway St Leonards, NSW, 2065.
Ethics committee country [1] 293848 0
Australia
Date submitted for ethics approval [1] 293848 0
30/11/2015
Approval date [1] 293848 0
24/02/2016
Ethics approval number [1] 293848 0

Summary
Brief summary
The purpose of this research project is to investigate whether treatment involving the earlier delivery of nutrition into the vein (intravenous nutrition) can improve the survival of patients who are scheduled to receive haematopoietic progenitor/stem cell transplantation (HPT), when compared with standard nutrition treatment.
Standard nutrition treatment after HPT in Australia does involve providing patients with intravenous nutrition, but intravenous nutrition is usually only started after all other options fail. After HPT, patients are normally fed orally (by mouth) or by enteral (gut tube) feeding. If either of these two options fails to provide enough nutrition for two or three days in a row, intravenous nutrition is often provided directly into the vein.
You may be eligible to join this research project if you are aged 18 years or above and have a haematological malignancy (blood cancer) for which you are about to commence conditioning chemoradiotherapy for allogeneic HPT.
Participants in this research project will be randomly (by chance) allocated to one of two groups. Participants in one group will continue to receive standard nutrition treatment. Participants in the other group will commence early intravenous nutrition prior to chemoradiotherapy.
If allocated to the intravenous nutrition arm of the research project, the amount of intravenous nutrition you will receive will be based on your medical condition and your body weight. The intravenous nutrition will also be adjusted based on the amount of food you are able to eat by mouth and/or are being fed by gut tube (enteral feeding).
The research project will enrol participants over a 3-year period. All participants will be monitored for a minimum of 1 year, up to a maximum of 4 years, in order to evaluate disease response, survival time, quality of life and costs of treatment.
It is hoped that the use of intravenous nutrition used early in allogeneic HPT will improve participant clinical outcomes, increase participant survival time and reduce costs to the acute care health system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61502 0
A/Prof Gordon Doig
Address 61502 0
Royal North Shore Hospital, Level 6, Intensive Care Unit, Pacific Highway, St Leonards, NSW 2065.
Country 61502 0
Australia
Phone 61502 0
61294632633
Fax 61502 0
Email 61502 0
gdoig@med.usyd.edu.au
Contact person for public queries
Name 61503 0
A/Prof Gordon Doig
Address 61503 0
Royal North Shore Hospital, Level 6, Intensive Care Unit, Pacific Highway, St Leonards, NSW 2065.
Country 61503 0
Australia
Phone 61503 0
61294632633
Fax 61503 0
Email 61503 0
gdoig@med.usyd.edu.au
Contact person for scientific queries
Name 61504 0
A/Prof Gordon Doig
Address 61504 0
Royal North Shore Hospital, Level 6, Intensive Care Unit, Pacific Highway, St Leonards, NSW 2065.
Country 61504 0
Australia
Phone 61504 0
61294632633
Fax 61504 0
Email 61504 0
gdoig@med.usyd.edu.au

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