Nutrition Intervention for Pancreatic Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT07554560
Status
Recruiting
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Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Pancreatic Neuroendocrine Tumor (NET)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Structured Lipid Medical Food — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 7, 2026
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Encala intervention
    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.

Primary Outcome Measure

Feasibility of Encala Intervention ( Enrollment Rate ) [ Time Frame: From enrollment to end of intervention at 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Edmond K Appiah, MPH
[email protected]
267-426-9381
Virginia Stallings, MD (PRINCIPAL_INVESTIGATOR)
Jefferson N Brownell, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104
Edmond K Appiah, MPH
[email protected]
267-426-9381
Ursina R Teitelbaum, MD (SUB_INVESTIGATOR)

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By research site
Children's Hospital of Philadelphia· Philadelphia, PAUniversity of Pennsylvania Abramson Cancer Center· Philadelphia, PA

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