Recruiting

SLMF

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07554560

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic Neuroendocrine Tumor (NET)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Structured Lipid Medical Food

Study Details

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic Neuroendocrine Tumor (NET)

Study ID

NCT07554560

Start date

Apr 7, 2026

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)
  • 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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Structured 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.

Primary outcome measure

  • Feasibility of Encala Intervention ( Enrollment Rate ) [ Time Frame: From enrollment to end of intervention at 8 weeks ]
  • Change in PROMIS Gastrointestinal Symptom Score [ Time Frame: Baseline to Week 8 ]
  • Feasibility of Encala Intervention ( Retention Rate ) [ Time Frame: Baseline to Week 8 ]
  • Feasibility of Encala Intervention ( Visit Completion) [ Time Frame: Baseline to Visit 8 ]
  • Feasibility of Encala Intervention ( Product Adherence ) [ Time Frame: Baseline to Visit 8 ]

Central Contacts and Locations

Central contacts

Edmond K Appiah, MPH

267-426-9381appiahe@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Edmond K Appiah, MPH

267-426-9381appiahe@chop.edu

Principal Investigator:

Virginia Stallings, MD

University of Pennsylvania Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Edmond K Appiah, MPH

267-426-9381appiahe@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Neuroendocrine Tumor
  • Exocrine pancreatic insufficiency
  • Fat malabsorption
  • Quality of life
  • Gastrointestinal symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-05-07.