Hematologic Neoplasms
Conditions
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTParenteral 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).
OTHERPragmatic standard care.
Nutrition support will be provided as per usual care.
Sponsors
Australasian Bone Marrow Transplant Recipient Registry
University of Roma La Sapienza
Northern Clinical School Intensive Care Research Unit, University of Sydney
University of Sydney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessment of bone marrow biopsy to determine transplant success will be undertaken independent of the knowledge of treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
* Patients who are already receiving parenteral nutrition at time of screening. * Patients with a documented licensing contraindication to parenteral nutrition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival time | Recruitment will run for 3 years, with a median follow-up time of 2 years. | Defined as time to relapse or death whichever occurs first |
Countries
Australia, New Zealand
Contacts
Primary ContactGordon S Doig, PhD
Backup ContactFiona Simpson, PhD
Outcome results
None listed