Overview

This trial is active, not recruiting.

Condition hematopoietic stem cell transplantation
Treatments omegaven, soybean oil lipid emulsion
Phase phase 1
Sponsor Alexandra N. Carey
Start date July 2016
End date August 2017
Trial size 20 participants
Trial identifier NCT02512718, P00016641

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
1 g/kg intravenous fish oil lipid emulsion (Omegaven) daily, provided starting day of transplant through day 30 or hospital discharge, whichever comes first.
omegaven Fish oil lipid emulsion
Comparison of FOLE vs. SOLE
(Active Comparator)
1 g/kg intravenous soybean oil lipid emulsion (SOLE) daily, provided starting day of transplant through day 30 or hospital discharge, whichever comes first.
soybean oil lipid emulsion Intralipid
Comparison of FOLE vs. SOLE

Primary Outcomes

Measure
Incidence of adverse events
time frame: From baseline to 100 days following stem cell transplantation

Secondary Outcomes

Measure
Essential fatty acid levels
time frame: Baseline, weekly for 4 weeks, 30 & 100 days following stem cell transplantation
Triglyceride levels
time frame: Baseline, weekly for 4 weeks, 30 & 100 days following stem cell transplantation

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

Inclusion Criteria: 1) myeloablative allogeneic HCT using either TBI (>1100 cGy) or busulfan in addition to other chemotherapeutic agents, 2) matched, related or unrelated HCT donor, and 3) diagnosis of a hematological malignancy. Exclusion Criteria: 1) unable or unwilling to return for day +30 or day +100 testing, 2) GVHD prophylaxis that includes rapamycin, 3) allergy to egg, fish, or soy/legume products, 4) other contraindication to PN or intravenous lipids, 5) unstable diabetes mellitus, 6) recent stroke, cardiac infarction or embolism, 7) undefined coma status, 8) lipid nephrosis, 9) pathological hyperlipidemia, 10) active/acute pancreatitis with hyperlipidemia, 11) history of parenteral nutrition use with SOLE prior to HCT or 12) co-enrollment in other interventional clinical studies.

Additional Information

Official title Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation
Principal investigator Alexandra N Carey, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.