Clinical trial · Interventional
Nutrition Intervention for Pancreatic Cancer
Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Pancreatic Neuroendocrine Tumor (NET) | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Structured Lipid Medical Food | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Encala intervention
- description
- 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.
- interventionNames
- Other: Structured Lipid Medical Food
Primary outcomes (5)
- measure
- Feasibility of Encala Intervention ( Enrollment Rate )
- timeFrame
- From enrollment to end of intervention at 8 weeks
- description
- Feasibility will be evaluated as a measure, including enrollment rate, retention rate, visit completion, and product adherence. Enrollment rate is defined as the proportion of eligible participants enrolled.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTMascarenhas MR, Mondick J, Barrett JS, Wilson M, Stallings VA, Schall JI. Malabsorption blood test: Assessing fat absorption in patients with cystic fibrosis and pancreatic insufficiency. J Clin Pharmacol. 2015 Aug;55(8):854-65. doi: 10.1002/jcph.484. Epub 2015 Mar 23. PMID 25689042
- RESULTStallings VA, Schall JI, Maqbool A, Mascarenhas MR, Alshaikh BN, Dougherty KA, Hommel K, Ryan J, Elci OU, Shaw WA. Effect of Oral Lipid Matrix Supplement on Fat Absorption in Cystic Fibrosis: A Randomized Placebo-Controlled Trial. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):676-680. doi: 10.1097/MPG.0000000000001213. PMID 27050056
- RESULTStallings VA, Tindall AM, Mascarenhas MR, Maqbool A, Schall JI. Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial. PLoS One. 2020 May 8;15(5):e0232685. doi: 10.1371/journal.pone.0232685. eCollection 2020. PMID 32384122
- RESULTTindall A, Mascarenhas M, Maqbool A, Stallings VA. Lysophosphatidylcholine-Rich Nutrition Therapy Increased Gut Absorption of Coingested Dietary Fat: a Randomized Controlled Trial. Curr Dev Nutr. 2023 Jul 31;7(9):101985. doi: 10.1016/j.cdnut.2023.101985. eCollection 2023 Sep. PMID 37671264