None listed
Conditions
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.
Interventions
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
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.
Sponsors
Shannon Petrovic
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing an initial MAC or RIC allogeneic stem cell transplant for a Haematological Malignancy Patients >18 years old
Exclusion criteria
Patients who have previously received a MAC or RIC allogeneic stem cell transplant
Outcome results
None listed