Structured lipid nutrition for people with pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm pilot enrolling about 18 adults with pancreatic ductal adenocarcinoma or pancreatic neuroendocrine tumors who have exocrine pancreatic insufficiency or fat malabsorption. Participants will consume 4–5 daily doses of a structured lipid medical food (Encala) providing roughly 400–500 kcal/day, mixed into preferred foods, beverages, or enteral feeds for eight weeks. Study visits at baseline, 4 weeks, and 8 weeks will measure gastrointestinal symptoms, dietary intake, body composition, physical function, and laboratory markers including plasma fatty acids. The trial is designed to test feasibility, tolerance, safety, and whether the product helps maintain lipid absorption and nutritional status in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• University of Pennsylvania Abramson Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Virginia A Stallings, MD — Children's Hospital of Philadelphia
• Study coordinator: Edmond K Appiah, MPH
• Email: appiahe@chop.edu
• Phone: 267-426-9381

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.