Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Children undergoing hematopoietic cell transplantation (HCT) for cancer or blood disorders
frequently develop gastrointestinal, metabolic and infectious complications related to
preparative high-dose chemotherapy and/or radiation-related toxicity. Parenteral nutrition
(PN) with lipid emulsion is commonly required while gastrointestinal complications preclude
adequate oral or enteral intake. PN and lipids may increase the risk of metabolic and
infectious complications in HCT patients who are inherently immune compromised.
Supplementation with omega-3 fatty acids has been linked to improvements in outcomes in
several populations. Provision of fish oil lipid emulsion (FOLE), rich in omega-3 fatty
acids, to children undergoing HCT is an innovative nutritional strategy that could mitigate
the metabolic and inflammatory side effects of HCT and its treatment. With its potential to
safely maintain essential fatty acid status, normalize blood lipids and alleviate the
inflammatory response to illness, the use of FOLE may reduce the risk of infections,
regimen-related toxicity, and other morbidities after HCT.
A randomized, controlled pilot study is proposed to test the safety and tolerability of FOLE,
compared to standard lipid emulsion, in 20 children during hospitalization for HCT. Results
of this study will provide the preliminary data needed for a larger clinical trial examining
the effect of FOLE on important clinical outcomes in this population. This novel approach to
nutritional care of this high-risk group will advance clinical knowledge of the impact of
FOLE, and will support further investigation into nutritional adjuncts to pediatric cancer
treatment.