Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03083327




Registration number
NCT03083327
Ethics application status
Date submitted
8/03/2017
Date registered
20/03/2017
Date last updated
28/04/2021

Titles & IDs
Public title
Prophylactic Early PN in HPT/BMT
Scientific title
Prophylactic Early Parenteral Nutrition in Patients Undergoing Hematopoietic Cell Transplantation: A Multi-centre Randomised Controlled Trial.
Secondary ID [1] 0 0
ACTRN12615001329550
Secondary ID [2] 0 0
NHMRC APP1108301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematologic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Parenteral nutrition.
Other interventions - Pragmatic standard care.

Active Comparator: Standard Care - 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.

Active Comparator: Early supplemental parenteral nutrition - 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.
The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake.


Other interventions: Parenteral nutrition.
Nutrition support will be provides as per usual, but oral and enteral intake will be topped up with a standard parenteral nutrition solution. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L).

Other interventions: Pragmatic standard care.
Nutrition support will be provided as per usual care.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease free survival time
Timepoint [1] 0 0
Recruitment will run for 3 years, with a median follow-up time of 2 years.

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
Sex
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2022
Actual
Sample size
Target
408
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Bone Marrow Transplant Recipient Registry
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Roma La Sapienza
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Northern Clinical School Intensive Care Research Unit, University of Sydney
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03083327
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gordon S Doig, PhD
Address 0 0
Northern Clinical School Intensive Care Research Unit, University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gordon S Doig, PhD
Address 0 0
Country 0 0
Phone 0 0
+61294632600
Fax 0 0
Email 0 0
gdoig@med.usyd.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03083327