A randomized comparison of early enteral nutrition and standard care post allogeneic stem cell transplantation.

Tolerability of early enteral feeding during allogeneic haematopoietic progenitor cell transplantation: a randomized comparison with ‘standard’ parenteral nutritional support.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000284561

Enrollment

Registered

2015-03-26

Start date

2015-03-12

Completion date

2017-05-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Nutritional support during allogeneic stem cell transplantation is imperative to prevent malnutrition. Nutrition support can be provided via either enteral (nasogastric) or parenteral (intravenous) feeding. Despite increased risks of infections and complications parenteral nutrition is used routinely at most transplant units due to patient's gastrointestinal toxicity at the time feeding is required. Recently a few small studies have shown benefits with early enteral nutrition in this group, including less infections, reduced risk of complications such as graft versus host disease, earlier neutrophil engraftment and improved survival. This study aims to assess tolerability of enteral feeding versus standard care (parenteral feeding) when commenced the day after transplantation, before the onset of gastrointestinal toxicity. This research study will determine which is the best form of nutritional supplementation for patients undergoing stem cell transplantation and the results will directly improve patient care as it will inform future clinical practice and lead to new clinical guideline development.

Interventions

This study aims to assess tolerability of enteral feeding versus standard care (parenteral feeding) when commenced the day after transplantation, before the onset of gastrointestinal toxicity. Patients will be randomised on admission to early enteral nutrition or standard care. The patients receiving enteral nutrition will have a fine bore nasogastric tube inserted the day after transplantation. Supplementary enteral feeding will commence immediately at 30ml/hr continuously to allow oral intake to continue ad libitum during the day. If oral intake declines enteral feeding rates will be adjusted until patients are meeting their goal nutrition requirement. If patients are intolerant of enteral feeding the nasogastric tube will be removed and parenteral nutrition commenced. If a low rate of enteral nutrition is tolerated but not the goal rate, top up parenteral feeding can be given. Supplementary feeding (enteral, parenteral or combination of both) will cease once patients are meeting 60% of nutrition requirements via oral intake post neutrophil engraftment.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Over 18 years old, no contraindications to nasogastric tube insertion, having an allogeneic transplant with cyclophosphamide and total body irradiation or fludarabine melphalan conditioning. Also must have ability to give informed consent.

Exclusion criteria

Known anatomic deformity preventing NGT insertion or undergoing a nonmyeloablative conditioning regimen (Fludarabine/ Cyclophosphamide or Fludarabine/total body irradiation).

Outcome results