Prophylactic early parenteral nutrition in patients undergoing haematopoietic cell transplantation: A multi-centre randomised controlled trial..

• Conditions: Haematological malignancies; Diet and Nutrition - Other diet and nutrition disorders; Blood - Haematological diseases; Cancer - Any cancer

• Registration Number: ACTRN12615001329550
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 408

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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival time, will be defined as time to relapse or death whichever occurs first. Time to relapse will be diagnosed by standard criteria defined by the European Group for Blood and Marrow Transplantation and the Australasian Bone Marrow Transplant Recipient Registry. [Recruitment will run for 3 years. Patients recruited in the first year of the study will be followed for 4 years. Patients recruited in the last year of the study will receive 1 year follow-up. ]