NCT03083327

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

November 23, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

March 8, 2017

Last Update Submit

April 26, 2021

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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.

Early supplemental parenteral nutrition

ACTIVE COMPARATOR

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.

Dietary Supplement: Parenteral nutrition.Other: Pragmatic standard care.

Interventions

Parenteral nutrition.DIETARY_SUPPLEMENT

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).

Early supplemental parenteral nutrition
Pragmatic standard care.OTHER

Nutrition support will be provided as per usual care.

Early supplemental parenteral nutritionStandard Care

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants will be assigned a biological sex based on their legal gender established at time of enrolment.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are already receiving parenteral nutrition at time of screening.
  • Patients with a documented licensing contraindication to parenteral nutrition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal North Shore Hospital

Sydney, New South Wales, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

RECRUITING

Christchurch Hospital, CDHB

Christchurch, New Zealand

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Gordon S Doig, PhD

    Northern Clinical School Intensive Care Research Unit, University of Sydney

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gordon S Doig, PhD

CONTACT

+61294632600gdoig@med.usyd.edu.au

Fiona Simpson, PhD

CONTACT

+61294632600fsimpson@med.usyd.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessment of bone marrow biopsy to determine transplant success will be undertaken independent of the knowledge of treatment assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 20, 2017

Study Start

November 23, 2017

Primary Completion

December 1, 2021

Study Completion

May 1, 2022

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

NZ(1)AU(2)