Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer
Children's Hospital of Philadelphia
Summary
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.
Description
This study is a prospective, single-arm pilot clinical trial designed to evaluate the feasibility, tolerance, safety, and potential effects of a structured lipid medical food (Encala®) in adult patients with pancreatic cancer, including pancreatic ductal adenocarcinoma (PDAC) and pancreatic neuroendocrine tumors (NET), who are at risk for exocrine pancreatic insufficiency (EPI) and fat malabsorption. Fat malabsorption is common in patients with pancreatic cancer due to impaired pancreatic enzyme function, leading to gastrointestinal symptoms, malnutrition, weight loss, and reduced quality of l…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pancreatic ductal adenocarcinoma or pancreatic neuroendocrine tumor diagnosis and age greater than or equal to 18 years * Life expectancy of 4 months or greater * Oral or enteral tube feeding for \> 60% daily calories * For patients with NET, evidence of GI dysfunction such as \>5% unintentional weight loss, increased number of bowel movements¸change in stool consistency (e.g., soft stool or diarrhea), as documented in the medical record and confirmed by the treating oncologist. Exclusion Criteria: * Pregnant or lactating * Unable to consume food by mouth (oral intake)…
Interventions
- OtherStructured Lipid Medical Food
Structured lipid medical food (Encala®) powder administered orally or via enteral feeding. Each dose consists of approximately 18.4 g (2 scoops) providing 100 kcal. Participants will receive 4-5 doses daily (total 400-500 kcal/day) for 8 weeks. The product is mixed with participant-selected foods, beverages, or tube feeding formula. Dosing is individualized based on weight status and recent weight loss.
Locations (2)
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania