Structured Lipid Medical Food for Pancreatic Cancer
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?
Virginia A Stallings, MD
Principal Investigator
Children's Hospital of Philadelphia
Jefferson N Brownell, MD
Principal Investigator
Children's Hospital of Philadelphia
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in nutritional biomarkers and quality of life.
What Are the Treatments Tested in This Trial?
Interventions
- Structured Lipid Medical Food
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants in this single-arm study will receive a structured lipid medical food (Encala®) administered daily for 8 weeks. The intervention consists of approximately 4-5 doses per day (approximately 400-500 kcal/day), mixed with food, beverages, or enteral nutrition as tolerated. The study will evaluate feasibility, tolerance, safety, and effects on fat absorption, gastrointestinal symptoms, and nutritional status in patients with pancreatic cancer.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
University of Pennsylvania
Collaborator
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