None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
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.
Outcome results
None listed