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Trial registered on ANZCTR


Registration number
ACTRN12619000942156
Ethics application status
Approved
Date submitted
14/05/2019
Date registered
5/07/2019
Date last updated
5/07/2019
Date data sharing statement initially provided
5/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility of Enteral Nutrition (EN) support in Allogeneic Haematopoietic Stem Cell Transplantation.
Scientific title
The feasibility of enteral nutrition support in patients undergoing Allogeneic Haematopoietic Stem Cell Transplantation.
Secondary ID [1] 298168 0
None
Universal Trial Number (UTN)
U1111-1233-3418
Trial acronym

Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematologic Neoplasms 312733 0
Enteral Nutrition 312817 0
Condition category
Condition code
Cancer 311315 311315 0 0
Leukaemia - Acute leukaemia
Cancer 311316 311316 0 0
Leukaemia - Chronic leukaemia
Cancer 311317 311317 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to determine whether enteral feeding is tolerated post allogeneic stem cell transplant. Patients will be recruited to the study during a pre-transplant appointment with the Transplant CNC and eligible participants will be consented and randomised into the intervention or control group.

The control group will receive standard nutrition practice throughout their admission, i.e. exclusive oral intake unless unable to tolerate and then Parenteral Nutrition will be considered.

The intervention group will receive continuous nasogastric enteral feeds in addition to standard nutrition practice. A fine-bore nasogastric feeding tube will be inserted on Day 0 of the transplant by a medical officer or accredited nurse. A standard polymeric feed formula (Isosource Protein Fibre, 1.3kcal/mL) will be administered by an enteral feeding pump that is set up by nursing staff. Enteral feeds will commence on Day +1 of the transplant at a rate of 20mL/hr for 24 hours continuously. If the feeds are tolerated, the rate will be increased by 10mL/day to a goal rate of 40mL/hr. The amount of enteral feed administered will be recorded by nursing staff within the electronic fluid balance chart and this will be monitored by the primary investigator to determine adherence to the intervention. Enteral feeds will remain at this rate throughout the patient’s admission and will be ceased once engraftment has occurred and the patient is meeting 60-75% of their nutrition requirements via oral intake.
Intervention code [1] 314455 0
Treatment: Other
Comparator / control treatment
The control group will receive standard nutrition practice throughout their admission, i.e. exclusive oral intake unless unable to tolerate and then Parenteral Nutrition will be considered.
Control group
Active

Outcomes
Primary outcome [1] 320047 0
The severity of gastrointestinal symptoms measured using the Memorial Symptom Assessment Scale, a paper-based questionnaire to be completed by the patient.
Timepoint [1] 320047 0
Assessed at baseline (Day 0 transplant), Day 7, Day 14, Day 21 and Day 28
Primary outcome [2] 320600 0
The percentage of total possible amount of enteral feeds delivered, assessed by referring to the electronic fluid balance chart completed by nursing staff within the patient's medical record.
Timepoint [2] 320600 0
Assessed on discharge.
Secondary outcome [1] 370365 0
Oral intake, determined by speaking with the patient and completing a food chart to capture 24 hours of oral intake
Timepoint [1] 370365 0
Will be assessed at baseline (Day 0 transplant), Day 7, Day 14, Day 21 and Day 28.
Secondary outcome [2] 371172 0
Neutrophil and platelet engraftment; determined by liaising with the medical/transplant team and consulting biochemical markers (including neutrophil and platelet count, measured daily within routine blood tests)
Timepoint [2] 371172 0
Will be assessed on discharge
Secondary outcome [3] 371173 0
Post transplant complications (including Graft Versus Host Disease); determined by liaising with the medical/transplant team
Timepoint [3] 371173 0
Will be assessed on discharge
Secondary outcome [4] 371174 0
Length of hospital stay
Timepoint [4] 371174 0
Will be assessed on discharge by determining the duration of inpatient hospital stay with the day of transplant considered as day 0 until the day of discharge, using data linkage to medical records.
Secondary outcome [5] 371175 0
Prescence of mucositis; according to the World Health Organisation levels of mucositis
Timepoint [5] 371175 0
Will be assessed at baseline (Day 0 transplant), Day 7, Day 14, Day 21 and Day 28.
Secondary outcome [6] 371176 0
Nutritional Status; determined using the Patient Generated Subjective Global Assessment (PGSGA)
Timepoint [6] 371176 0
Will be assessed at baseline (Day 0 transplant), Day 7, Day 14, Day 21 and Day 28.
Secondary outcome [7] 371248 0
Quality of life; determined by using the SF-36 quesitonnaire
Timepoint [7] 371248 0
Will be assessed at baseline (Day 0 transplant), Day 7, Day 14, Day 21 and Day 28.

Eligibility
Key inclusion criteria
Patients undergoing an initial MAC or RIC allogeneic stem cell transplant for a Haematological Malignancy
Patients >18 years old
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have previously received a MAC or RIC allogeneic stem cell transplant

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)
Randomization will be conducted through adhering to the allocation concealment and permuted block randomization method.

5 cards labeled ‘intervention’ and 5 cards labeled ‘control’ will be placed in opaque envelopes. Envelopes will then undergo block randomization and positioned in a box. The Chief Investigator will open an envelope after consenting a participant and assign the participant to the relevant group.
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
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
Recruitment postcode(s) [1] 26479 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 302703 0
Hospital
Name [1] 302703 0
Sydney Local Health District (specifially Royal Prince Alfred Hospital; Nutrition & Dietetics Department) will be providing the enteral feeds and funding staff time as part of their standard practice
Address [1] 302703 0
Royal Prince Alfred Hospital, Nutrition & Dietetics Department - Building 12, Corner of Missenden Road & Grose Street, CAMPERDOWN NSW 2050
Country [1] 302703 0
Australia
Primary sponsor type
Individual
Name
Shannon Petrovic
Address
Royal Prince Alfred Hospital,Nutrition & Dietetics Department, Building 12, Corner of Missenden Road & Grose Street, CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 302701 0
None
Name [1] 302701 0
Address [1] 302701 0
Country [1] 302701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303313 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 303313 0
RESEARCH ETHICS AND GOVERNANCE OFFICE
ROYAL PRINCE ALFRED HOSPITAL
CAMPERDOWN NSW 2050
Ethics committee country [1] 303313 0
Australia
Date submitted for ethics approval [1] 303313 0
Approval date [1] 303313 0
02/05/2019
Ethics approval number [1] 303313 0

Summary
Brief summary
The purpose of this study is to determine whether enteral feeding (via a tube through the mouth to the stomach) is tolerated post allogeneic Haematopoietic stem cell transplant.

Who is it for?
Patients 18 and over that have been diagnosed with a haematological malignancy and are planned for an initial allogeneic haematopoietic stem cell transplant.

Study details:
Patients will be recruited to the study during a pre-transplant appointment with the Transplant clinical nurse consultant (CNC) and eligible patients will be consented and randomly allocated (by chance) to the intervention or control group.

The study will examine the feasibility of using enteral feeding post transplant. Following transplantation, both groups will continue with standard nutrition practice, by eating and drinking orally as tolerated. If patients are unable to tolerate oral intake, Parenteral Nutrition may be considered. One group (the intervention group) will also have a nasogastric tube inserted on the day of the transplant and will receive enteral feeds throughout the patient's admission. The rate of feed will start at 20mL/hr for 24 hours continuously and will be increased by 10mL/day to a goal rate of 40mL/hr. Enteral feeds will cease once the patient is meeting 60-75% of their nutrition requirements via their oral intake and they have engrafted.

It is hoped that this study will assist in better addressing the optimal use of nutrition support to improve outcomes post transplant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93234 0
Miss Shannon Petrovic
Address 93234 0
Royal Prince Alfred Hospital, Nutrition & Dietetics Department, Building 12, Corner of Missenden Road & Grose Street, CAMPERDOWN NSW 2050
Country 93234 0
Australia
Phone 93234 0
+61 2 9515 8053
Fax 93234 0
Email 93234 0
shannon.petrovic@health.nsw.gov.au
Contact person for public queries
Name 93235 0
Miss Shannon Petrovic
Address 93235 0
Royal Prince Alfred Hospital, Nutrition & Dietetics Department, Building 12, Corner of Missenden Road & Grose Street, CAMPERDOWN NSW 2050
Country 93235 0
Australia
Phone 93235 0
+61 2 9515 8053
Fax 93235 0
Email 93235 0
shannon.petrovic@health.nsw.gov.au
Contact person for scientific queries
Name 93236 0
Miss Shannon Petrovic
Address 93236 0
Royal Prince Alfred Hospital, Nutrition & Dietetics Department, Building 12, Corner of Missenden Road & Grose Street, CAMPERDOWN NSW 2050
Country 93236 0
Australia
Phone 93236 0
+61 2 9515 8053
Fax 93236 0
Email 93236 0
shannon.petrovic@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results