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

NCT02512718 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Hematopoietic Stem Cell Transplantation

Interventions

DRUG

Omegaven

Comparison of FOLE vs. SOLE

DRUG

Soybean oil lipid emulsion

Comparison of FOLE vs. SOLE

Sponsors & Collaborators

  • Alexandra N. Carey

    lead OTHER

Principal Investigators

  • Alexandra N Carey, MD · Boston Children's Hospital

  • Christopher Duggan, MD, MPH · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2023-05-18
Completion
2023-05-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02512718 on ClinicalTrials.gov