Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation

Parenteral nutrition (PN) is often necessary for children undergoing allogeneic allogeneic bone marrow, cord, or peripheral blood stem cell (from any donor, including haploidentical donor) hematopoietic cell transplantation (HCT) to avoid malnutrition and growth failure due to the gastrointestinal toxicity associated with preparative myeloablative conditioning regimens. Intravenous lipid emulsion is a required component of PN to provide energy and essential fatty acids when oral or enteral intake is nil or minimal. Soybean oil lipid emulsion (SOLE) is the standard lipid emulsion used in PN. Complications such as metabolic instability, cholestasis, hypertriglyceridemia, and anorexia, which are common during HCT, may also be attributable to the SOLE component of PN. Fish oil based lipid emulsion (FOLE) is used in certain populations and is associated with improved outcomes, specifically in infants with intestinal failure and PN associated cholestasis. It has been reported that supplementation with omega-3 fatty acids from fish oil emulsion may preserve lean body mass, improve quality of life, and decrease length of hospital stay. Provision of FOLE to children undergoing HCT is a novel and innovative strategy to potentially mitigate the metabolic and inflammatory side effects of HCT and its treatment.

HYPOTHESIS: The provision of FOLE is safe and well tolerated in children following HCT. Our aims are to determine the safety profile (as measured by the number of grade 2 or higher adverse events) and tolerability of intravenous FOLE (as measured by serum fatty acid profiles) among children undergoing HCT compared to children receiving SOLE.

HYPOTHESIS: The provision of FOLE is associated with reduced incidence of hypertriglyceridemia in children following HCT, compared to children receiving SOLE and our aim is to determine the number (and percentage) of subjects with fasting hypertriglyceridemia during the trial. To explore trends in associations with other relevant outcomes, other exploratory outcomes (inflammatory biomarkers, body composition measurements, and quality of life indicators) will be assessed in both groups of children following HCT.

METHODS: This is a randomized, controlled, unblinded pilot study to test the safety and tolerability of FOLE, compared to standard SOLE, in children hospitalized for HCT with an underlying hematologic malignancy or myelodysplasic syndrome.

Children cared for in the Dana-Farber Cancer Institute/Boston Children's Cancer and Blood Disorders Center and who will be admitted to BCH for allogeneic HCT will be enrolled (10 subjects in each arm). Patients will be included if they meet all of the entry criteria and none of the exclusion criteria.