Prophylactic Early PN in HPT/BMT

Hematologic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03083327
• Other study ID #: NHMRC APP1108301
• Secondary ID: ACTRN12615001329
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2017
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2021
• Source: University of Sydney
• Contact: Gordon S Doig, PhD
• Phone: +61294632600
• Email: gdoig[@]med.usyd.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: May 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

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).

Other:
• Pragmatic standard care.
Nutrition support will be provided as per usual care.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal North Shore Hospital	Sydney	New South Wales
New Zealand	Christchurch Hospital, CDHB	Christchurch

Sponsors (4)

Lead Sponsor	Collaborator
University of Sydney	Australasian Bone Marrow Transplant Recipient Registry, Northern Clinical School Intensive Care Research Unit, University of Sydney, University of Roma La Sapienza

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.