Clinical trial NCT03083327: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Neoplasms
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Australasian Bone Marrow Transplant Recipient Registry
name: University of Roma La Sapienza
name: Northern Clinical School Intensive Care Research Unit, University of Sydney
First posted: 2017-03-20
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Disease free survival time
timeFrame: Recruitment will run for 3 years, with a median follow-up time of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Christchurch
country: New Zealand
facility: Christchurch Hospital, CDHB
Study officials:
affiliation: Northern Clinical School Intensive Care Research Unit, University of Sydney
name: Gordon S Doig, PhD
role: PRINCIPAL_INVESTIGATOR
References: