The safety and tolerability of intravenous fish oil lipid emulsion in children undergoing hematopoietic cell transplantation

Summary:

Hematopoietic Stem cell transplant (HSCT) is a potentially life-saving treatment for many patients with blood cancers and is generally the preferred approach for children with a high risk of relapsed disease. However, HSCT is associated with significant toxicity from preparative chemo- and radiotherapy resulting in severe mucositis (redness and ulcerations that can occur anywhere along the GI track) and other GI complications. As a result, children often require parenteral nutrition (PN) during these complications in order to maintain adequate nutritional intake. However, the evidence suggests that the only lipid emulsion approved in the US, soybean oil lipid emulsion (SOLE), may be a contributor to complications associated with PN including metabolic and infectious complications which when combined with immunosuppressants for the HSCT, may lead to end organ toxicity. This Phase I trial will determine the safety profile of intravenous fish oil lipid emulsion (FOLE) in children 6 to 18 years of age. FOLE is high in omega-3 fatty acids which are linked to improvements in inflammatory biomarkers, improvements in quality of life, and decreased length of hospital stay. 

Trial Registartion: ClinicalTrials.gov Identifier: NCT02512718