RecruitingACTRN12619000942156

The feasibility of Enteral Nutrition (EN) support in Allogeneic Haematopoietic Stem Cell Transplantation.

The feasibility of enteral nutrition support in patients undergoing Allogeneic Haematopoietic Stem Cell Transplantation.


Sponsor

Shannon Petrovic

Enrollment

10 participants

Start Date

May 29, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Allogeneic haematopoietic stem cell transplantation (HSCT) — a procedure where a patient receives new blood-forming cells from a donor — is used to treat blood cancers and other serious blood conditions. The treatment process is gruelling, and patients often struggle to eat enough to meet their nutritional needs because of nausea, mouth sores, and loss of appetite. Poor nutrition during this period can slow recovery and increase complications. This feasibility study is testing whether delivering nutrition through a thin tube passed through the nose into the stomach (called enteral feeding) is practical and well-tolerated following stem cell transplantation. Half of the participants will receive standard care (eating and drinking as able, with intravenous nutrition if needed), while the other half will also have a nasogastric tube inserted on transplant day and receive continuous tube feeds throughout their admission. The study is open to adults aged 18 and over who are undergoing their first allogeneic stem cell transplant for a blood cancer. People who have previously had this type of transplant are not eligible. If tube feeding proves feasible and acceptable, the next step would be a larger trial to confirm whether it actually improves outcomes like recovery speed, infection rates, and time in hospital.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

NSW, Australia

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ACTRN12619000942156


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