Prophylactic Early PN in HPT/BMT

Not Applicable

• Conditions: Hematologic Neoplasms
• Interventions: Dietary Supplement: Parenteral nutrition.; Other: Pragmatic standard care.

• Registration Number: NCT03083327
• Lead Sponsor: University of Sydney

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Study Start: 2017-11-23
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-12-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 408

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early supplemental parenteral nutrition	Pragmatic standard care.	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. The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake.
Standard Care	Pragmatic standard care.	The control group in this study is pragmatic standard nutrition care. Currently after a bone marrow transplant in Australia, patients are normally fed orally for as long as possible. If oral intake fails to provide sufficient calories for a period of two to three days, enteral or parenteral nutrition may be provided.
Early supplemental parenteral nutrition	Parenteral nutrition.	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. The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake.

Primary Outcome Measures

Name	Time	Method
Disease free survival time	Recruitment will run for 3 years, with a median follow-up time of 2 years.	Defined as time to relapse or death whichever occurs first

Trial Locations

Locations (3)

Royal North Shore Hospital; 🇦🇺 Sydney, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Christchurch Hospital, CDHB; 🇳🇿 Christchurch, New Zealand