Prophylactic Early PN in HPT/BMT

Prophylactic Early Parenteral Nutrition in Patients Undergoing Hematopoietic Cell Transplantation: A Multi-centre Randomised Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Neoplasms
• Intervention / Treatment: Other: Pragmatic standard care.; Dietary supplement: Parenteral nutrition.

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 Type: Interventional
• Enrollment (Anticipated): 408
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gordon S Doig, PhD; Phone Number: +61294632600; Email: gdoig@med.usyd.edu.au
• Study Contact Backup: Name: Fiona Simpson, PhD; Phone Number: +61294632600; Email: fsimpson@med.usyd.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Recruiting
      • Royal North Shore Hospital
      • Contact: Site Investigator
  • South Australia
    • Adelaide, South Australia, Australia
      • Recruiting
      • Royal Adelaide Hospital
      • Contact: Site Investigator
• New Zealand
  • Christchurch, New Zealand
    • Recruiting
    • Christchurch Hospital, CDHB
    • Contact: Site Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Pragmatic standard care.; Nutrition support will be provided as per usual care.
Active Comparator: Early supplemental 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.	Other: Pragmatic standard care.; Nutrition support will be provided as per usual care.; Dietary supplement: Parenteral nutrition.; Nutrition support will be provides as per usual, but oral and enteral intake will be topped up with a standard parenteral nutrition solution. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sydney
• Collaborators: University of Roma La Sapienza; Australasian Bone Marrow Transplant Recipient Registry; Northern Clinical School Intensive Care Research Unit, University of Sydney
• Investigators: Principal Investigator: Gordon S Doig, PhD, Northern Clinical School Intensive Care Research Unit, University of Sydney

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: NHMRC APP1108301; ACTRN12615001329550 (Registry Identifier: Australian New Zealand Clinical Trials Registery); U1111-1194-5952 (Other Identifier: WHO Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No