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Prophylactic Early PN in HPT/BMT

Primary Purpose

Hematologic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Parenteral nutrition.
Pragmatic standard care.
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematologic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal North Shore HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Christchurch Hospital, CDHBRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard Care

Early supplemental parenteral nutrition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Disease free survival time
Defined as time to relapse or death whichever occurs first

Secondary Outcome Measures

Full Information

First Posted
March 8, 2017
Last Updated
April 26, 2021
Sponsor
University of Sydney
Collaborators
Australasian Bone Marrow Transplant Recipient Registry, University of Roma La Sapienza, Northern Clinical School Intensive Care Research Unit, University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT03083327
Brief Title
Prophylactic Early PN in HPT/BMT
Official Title
Prophylactic Early Parenteral Nutrition in Patients Undergoing Hematopoietic Cell Transplantation: A Multi-centre Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sydney
Collaborators
Australasian Bone Marrow Transplant Recipient Registry, University of Roma La Sapienza, Northern Clinical School Intensive Care Research Unit, University of Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessment of bone marrow biopsy to determine transplant success will be undertaken independent of the knowledge of treatment assignment.
Allocation
Randomized
Enrollment
408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Early supplemental parenteral nutrition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Parenteral nutrition.
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Pragmatic standard care.
Intervention Description
Nutrition support will be provided as per usual care.
Primary Outcome Measure Information:
Title
Disease free survival time
Description
Defined as time to relapse or death whichever occurs first
Time Frame
Recruitment will run for 3 years, with a median follow-up time of 2 years.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participants will be assigned a biological sex based on their legal gender established at time of enrolment.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gordon S Doig, PhD
Phone
+61294632600
Email
gdoig@med.usyd.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona Simpson, PhD
Phone
+61294632600
Email
fsimpson@med.usyd.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon S Doig, PhD
Organizational Affiliation
Northern Clinical School Intensive Care Research Unit, University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Investigator
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Investigator
Facility Name
Christchurch Hospital, CDHB
City
Christchurch
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Investigator

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prophylactic Early PN in HPT/BMT

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