RecruitingNot ApplicableNCT07554560

Nutrition Intervention for Pancreatic Cancer

Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer


Sponsor

Children's Hospital of Philadelphia

Enrollment

18 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • Pregnant or lactating
  • Unable to consume food by mouth (oral intake)
  • Allergy to soy lecithin product ingredients
  • Psychosocial environment for which study participation may be difficult for subject or family, as confirmed by medical team
  • Military service members, Reserve Service members, National Guard members, Department of Defense (DoD) civilians, and DoD contractors
  • Patients with diminished capacity to consent

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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 Philadelphia

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT07554560


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