Structured lipid nutrition for people with pancreatic cancer
Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer
NA · Children's Hospital of Philadelphia · NCT07554560
Try a structured lipid medical food (Encala) to help people with pancreatic cancer who have trouble absorbing fat.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia (other) |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT07554560 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with pancreatic ductal adenocarcinoma or pancreatic neuroendocrine tumors who have signs of exocrine pancreatic insufficiency or fat malabsorption, can take at least 60% of calories orally or by enteral feed, and have a life expectancy of four months or more.
Not a fit: People who cannot take food by mouth, are allergic to soy lecithin ingredients, have very limited life expectancy, or lack capacity to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could improve fat absorption, reduce GI symptoms, help maintain weight and nutritional status, and improve quality of life for people with pancreatic cancer.
How similar studies have performed: Structured lipid formulations like Encala have demonstrated benefit for fat absorption in conditions such as cystic fibrosis, but their use specifically in pancreatic cancer populations is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Ductal Adenocarcinoma, Pancreatic Neuroendocrine Tumor, Exocrine pancreatic insufficiency, Fat malabsorption, Quality of life, Gastrointestinal symptoms