18 Participants NeededMy employer runs this trial

Structured Lipid Medical Food for Pancreatic Cancer

Recruiting at 1 trial location
EK
Overseen ByEdmond K Appiah, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients with pancreatic cancer (pancreatic ductal adenocarcinoma (PDAC) and pancreatic neuroendocrine tumor (NET)) commonly experience fat malabsorption due to exocrine pancreatic insufficiency (EPI) and leads to gastrointestinal (GI) symptoms, malnutrition, weight loss, and reduced quality of life (QoL). Current standard treatment, pancreatic enzyme replacement therapy (PERT), is limited by suboptimal adherence, high cost, and partial effectiveness to prevent fat malabsorption. The objective of the study is to assess the feasibility and maintenance of lipid absorption function of a structured lipid medical food (SLMF; Encala®) powder in subjects with PDAC and NET with EPI.

Who Is on the Research Team?

VA

Virginia A Stallings, MD

Principal Investigator

Children's Hospital of Philadelphia

JN

Jefferson N Brownell, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a neuroendocrine tumor and recent GI problems like weight loss or diarrhea.
Life expectancy of 4 months or greater
Oral or enteral tube feeding for > 60% daily calories
See 1 more

Exclusion Criteria

Pregnant or lactating
Unable to consume food by mouth (oral intake)
Allergy to soy lecithin product ingredients
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the structured lipid medical food (Encala®) for 8 weeks, consuming 4-5 daily doses mixed with food, beverages, or enteral feeding formulations.

8 weeks
3 visits (in-person) at baseline, 4 weeks, and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in nutritional biomarkers and quality of life.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Structured Lipid Medical Food

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Encala interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+