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

NCT02512718 | Completed Phase 1 DMC

• 1 other identifier: P00016641
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intravenous fat emulsions; fish oil lipid emulsion

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Number and type of adverse events, categorized according to NCI Common Toxicity Criteria

  From baseline to 100 days following stem cell transplantation

Secondary Outcomes (2)

• Essential fatty acid levels

  Baseline, weekly for 4 weeks, 30 & 100 days following stem cell transplantation

• Triglyceride levels

  Baseline, weekly for 4 weeks, 30 & 100 days following stem cell transplantation

Other Outcomes (3)

• Inflammatory markers

  Baseline, weekly for 4 weeks, 30 & 100 days following stem cell transplantation

• Quality of life assessment

  Baseline, 30 & 100 days following stem cell transplantation

• Body composition

  Baseline, 30 & 100 days following stem cell transplantation

Study Arms (2)

Fish Oil Lipid Emulsion

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.

Drug: Omegaven

Soybean Oil Lipid Emulsion

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.

Drug: Soybean oil lipid emulsion

Interventions

Omegaven DRUG

Comparison of FOLE vs. SOLE

Also known as: Fish oil lipid emulsion

Fish Oil Lipid Emulsion

Soybean oil lipid emulsion DRUG

Comparison of FOLE vs. SOLE

Also known as: Intralipid

Soybean Oil Lipid Emulsion

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Planned myeloablative allogeneic bone marrow, cord, or peripheral blood stem cell (from any donor, including haploidentical donor) HCT conditioning regimen using either TBI (planned cumulative dose \>1100cGy) or busulfan in addition to other chemotherapeutic agents
• Planned related or unrelated bone marrow donor matched at a minimum of out of 10 human leukocyte antigen (HLA) loci (HLA-A, -B, -C, -DRB1, and -DQ), or planned related or unrelated cord blood donor matched at a minimum of 4 out of 6 HLA loci (HLA-A, -B, and -DRB1), or a haplo- identical related donor; typing must be at the allele level for unrelated donors, antigen level typing is acceptable for related donors
• Diagnosis of a hematological malignancy including myelodysplasia.

You may not qualify if:

• Unable or unwilling to return for day +30 or day +100 testing
• GVHD prophylaxis that includes rapamycin
• Allergy to egg, fish (including seafood and/or shellfish), or soy/legume products
• a. Patients with egg, fish (including seafood and/or shellfish), or soy/legume intolerance without a documented allergy may still be included at the discretion of the PI and patient/family
• Other contraindication to PN or intravenous lipids
• Unstable diabetes mellitus
• Stroke, cardiac infarction or embolism within 6 months prior to HCT OR current, ongoing treatment for stroke, infarction, and/or embolism
• Undefined coma status,
• Lipid nephrosis,
• Pathological hyperlipidemia (2 consecutive fasting triglyceride levels \> 500 mg/dL),
• Active/acute pancreatitis with hyperlipidemia (fasting triglyceride levels \> 500 mg/dL) (see section 3.5 for specific diagnostic criteria),
• History of parenteral nutrition (PN) use with any intravenous lipid product or use of any intravenous lipid product without PN within 6 months prior to HCT
• Co-enrollment in other interventional clinical studies.
• Clinically significant pleural or pericardial effusion
• Aluminum toxicity, especially in patients with renal impairment

Sponsors & Collaborators

• Alexandra N. Carey: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

fish oil triglycerides; soybean oil, phospholipid emulsion

Study Officials

• Alexandra N Carey, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Christopher Duggan, MD, MPH

  Boston Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 31, 2015
• Study Start: June 1, 2016
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)