Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer
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.
Detailed description
This study is a prospective, single-arm pilot clinical trial designed to evaluate the feasibility, tolerance, safety, and potential effects of a structured lipid medical food (Encala®) in adult patients with pancreatic cancer, including pancreatic ductal adenocarcinoma (PDAC) and pancreatic neuroendocrine tumors (NET), who are at risk for exocrine pancreatic insufficiency (EPI) and fat malabsorption. Fat malabsorption is common in patients with pancreatic cancer due to impaired pancreatic enzyme function, leading to gastrointestinal symptoms, malnutrition, weight loss, and reduced quality of life. The structured lipid medical food evaluated in this study is designed to improve fat absorption without requiring pancreatic lipase or bile acids, potentially addressing a critical gap in nutritional support for this population. This study will enroll approximately 18 adult participants recruited through the Penn Pancreatic Cancer Research Center. Participants will receive the study intervention over an 8-week period, during which they will consume 4-5 daily doses of the structured lipid medical food (approximately 400-500 kcal/day), mixed with preferred foods, beverages, or enteral feeding formulations. Participants will undergo study assessments at baseline, 4 weeks, and 8 weeks. These assessments will include evaluation of gastrointestinal symptoms, nutritional status, dietary intake, body composition, and physical function. Laboratory measures, including plasma fatty acids and nutritional biomarkers, will be collected to assess changes in fat absorption and nutritional status. A malabsorption blood test (MBT) will also be used to evaluate intestinal fat absorption. The primary outcomes of this study are feasibility, tolerance, and safety of the intervention. Secondary outcomes include changes in gastrointestinal symptoms, body weight, nutritional biomarkers, and measure of fat absorption (MBT) at baseline. Findings from this pilot study will provide preliminary data on the feasibility and potential clinical benefits of this nutritional intervention and will inform the design of future larger-scale studies aimed at improving nutritional management and quality of life in patients with pancreatic cancer.
Arms & interventions
- OtherStructured 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.
Outcome measures
Primary
Feasibility of Encala Intervention ( Enrollment Rate )
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.
Time frame: From enrollment to end of intervention at 8 weeks
Change in PROMIS Gastrointestinal Symptom Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scale measures gastrointestinal symptom severity across domains such as diarrhea, belly pain, constipation, nausea, and vomiting. 'Never/Not all' indicates improved/better gastrointestinal symptoms, while "Always/Very bad " indicates worse gastrointestinal symptoms.
Time frame: Baseline to Week 8
Feasibility of Encala Intervention ( Retention Rate )
Retention rate is defined as the proportion of participants completing the study.
Time frame: Baseline to Week 8
Feasibility of Encala Intervention ( Visit Completion)
Visit completion is defined as the proportion of scheduled visits completed
Time frame: Baseline to Visit 8
Feasibility of Encala Intervention ( Product Adherence )
Product adherence is defined as the proportion of prescribed doses consumed based on daily logs and returned product records.
Time frame: Baseline to Visit 8
Secondary
Baseline Malabsorption Blood Test (MBT) Area Under the Curve
Time frame: Baseline and Week 8
Change in Total Plasma Fatty Acid Concentration
Time frame: Baseline, 4 weeks, and 8 weeks
Change in Serum Prealbumin
Time frame: Baseline, 4 weeks, and 8 weeks
Change in Serum Vitamin A
Time frame: Baseline, 4 weeks, and 8 weeks
Change in Plasma Choline
Time frame: Baseline and 8 weeks
Change in Dietary Intake
Time frame: Baseline, 4 weeks, and 8 weeks
Change in Physical Function Short Physical Performance Battery (SPPB)
Time frame: Baseline, 4 weeks, and 8 weeks
Change in Quality of Life (PROMIS) Questionnaires
Time frame: Baseline, 4 weeks, and 8 weeks
Change in Hand Grip Strength
Time frame: Baseline, 4 weeks, and Week 8
Change in Body Weight
Time frame: Baseline, 4 weeks, and 8 weeks
Change in Fat Mass (kg) measured by DXA
Time frame: Baseline and 8 weeks
Change in Body Mass Index
Time frame: Baseline, Week 4, and Week 8
Changes in Mid-Upper Arm Circumference (MUAC)
Time frame: baseline, Week 4, and Week 8.
Change in Skinfold Thickness
Time frame: baseline, Week 4, and Week 8.
Change in Lean Body Mass (kg) measured by DXA
Time frame: Baseline and Week 8
Eligibility criteria
Study locations (2)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
References
- Mascarenhas 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.(PubMed)
- Stallings 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.(PubMed)
- Stallings 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.(PubMed)
- Tindall 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.(PubMed)