RecruitingACTRN12611001084976

What is the best form of nutrition support during an Allogeneic Transplant

A randomized comparison of tolerance of parenteral nutrition and enteral feeding as nutritional support during allogeneic haematopoietic progenitor cell transplantation

Sponsor

A/Prof Glen Kennedy

Enrollment

66 participants

Start Date

Sep 16, 2011

Study Type

Interventional

Conditions

Allogeneic transplants Nutrition support

Summary

Patients undergoing a Stem Cell Transplant (SCT) often have difficulty eating adequately due to the side effects of treatment and malnutrition can occur which is associated with poor outcomes post transplant. The best type of nutrition support to be given during a SCT is controversial and Parenteral Nutrition/ Intravenous feeding (PN) is usually given over Enteral Nutrition/ Nasogastric feeding (EN) despite the increased cost, infection risks and other complications associated with PN. This project aims to determine whether PN or EN is better tolerated by SCT patients who are unable to eat adequately. If EN is successfully tolerated this will eliminate the risks, complications and cost associated with routine use of PN. This research will directly improve future patient care and will result in changes to current nutrition support practices and lead to improved outcomes for cancer transplant patients.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of providing nutrition support to people who cannot eat enough during a stem cell transplant: intravenous (IV) feeding directly into the bloodstream, versus tube feeding through the nose into the stomach. Currently most hospitals use IV feeding, but it is more expensive and has more risks. Researchers want to find out if stomach tube feeding is a safer and equally effective alternative. You may be eligible if: - You are between 18 and 65 years old - You are undergoing an allogeneic (donor) stem cell transplant - You are able to understand and sign a consent form You may NOT be eligible if: - You have a physical blockage that prevents placing a feeding tube - You have severe mouth sores (Grade 3-4 mucositis), bowel blockage (ileus), or uncontrollable vomiting Talk to your doctor about whether this trial might be right for you.

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

Patients who require supplementary feeding when undergoing an Allogeneic transplant will be randomised to supplemental nutritional support by parenteral nutrition (PN) versus enteral nutrition (EN) on a 1:1 basis. PN will be administered through a central venous catheter using a standard central parenteral nutrition solution including intravenous vitamin supplementation. EN will be a standard 1.25kcal/ml ready to hang formula administered through a nasogastric tube inserted at the onset of supplemental feeding. The feeding rate and goal to meet requirements will be as per the ward Dietitian. Feeding will continue until patients are able to meet 60% of requirements through oral intake for atleast one day. If a patient does not tolerate their mode of feeding they can be changed to the alternate mode of feeding at any time.

Locations(1)

Australia

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ACTRN12611001084976

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