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Spots Global Cancer Trial Database for Prophylactic Early PN in HPT/BMT

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Trial Identification

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 ID: NCT03083327

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Royal North Shore Hospital, Sydney, New South Wales, Australia

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Christchurch Hospital, CDHB, Christchurch, , New Zealand

Contact Details

Name: Gordon S Doig, PhD

Affiliation: Northern Clinical School Intensive Care Research Unit, University of Sydney

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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