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: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandra N. Carey
• Treatments: Soybean oil, phospholipid emulsion

Criteria

Inclusion:

1. 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

2. 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

3. Diagnosis of a hematological malignancy including myelodysplasia.

Exclusion:

1. Unable or unwilling to return for day +30 or day +100 testing

2. GVHD prophylaxis that includes rapamycin

3. 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

4. Other contraindication to PN or intravenous lipids

5. Unstable diabetes mellitus

6. Stroke, cardiac infarction or embolism within 6 months prior to HCT OR current, ongoing treatment for stroke, infarction, and/or embolism

7. Undefined coma status,

8. Lipid nephrosis,

9. Pathological hyperlipidemia (2 consecutive fasting triglyceride levels > 500 mg/dL),

10. Active/acute pancreatitis with hyperlipidemia (fasting triglyceride levels > 500 mg/dL) (see section 3.5 for specific diagnostic criteria),

11. 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

12. Co-enrollment in other interventional clinical studies.

13. Clinically significant pleural or pericardial effusion

a) If a pleural or pericardial effusion is noted on the pre-transplant testing echocardiogram, the PI will contact the cardiologist to ask if it is clinically significant. If clinically insignificant pleural or pericardial effusion exists at baseline AND the patient is randomized to FOLE, the PI will seek approval for inclusion with the primary attending and decide upon appropriate monitoring to include close clinical observation, cardiology consultation and/or serial echocardiograms where appropriate.

14. Aluminum toxicity, especially in patients with renal impairment

15. Risk of infection

16. Refeeding syndrome