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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252510749 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Encala intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Lipid Medical Food | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to Week 8 |
| Feasibility of Encala Intervention ( Retention Rate ) | Retention rate is defined as the proportion of participants completing the study. | Baseline to Week 8 |
| Feasibility of Encala Intervention ( Visit Completion) | Visit completion is defined as the proportion of scheduled visits completed | 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. | Baseline to Visit 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Malabsorption Blood Test (MBT) Area Under the Curve | Change in intestinal fat absorption as measured by the malabsorption blood test (MBT), defined by the area under the curve (AUC) for pentadecanoic acid and heptadecanoic acid. | Baseline and Week 8 |
| Change in Total Plasma Fatty Acid Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edmond K Appiah, MPH | Contact | 267-426-9381 | appiahe@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Virginia A Stallings, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Jefferson N Brownell, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25689042 | Result | 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. | |
| 27050056 | Result | 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. |
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Individual participant data (IPD) will not be shared due to the small sample size and the sensitive nature of clinical data in this pilot study population. Data collected in this study contain potentially identifiable health information, and sharing individual-level data may increase the risk of participant re-identification. Results from this study will be reported in aggregate form to protect participant confidentiality. Any future data sharing would require appropriate institutional review board (IRB) approval and data use agreements.
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Change in total plasma fatty acid concentration as a measure of dietary fat absorption. |
| Baseline, 4 weeks, and 8 weeks |
| Change in Serum Prealbumin | Change in serum prealbumin concentration as a marker of nutritional status. | Baseline, 4 weeks, and 8 weeks |
| Change in Serum Vitamin A | Change in serum vitamin A concentration as a marker of nutritional status | Baseline, 4 weeks, and 8 weeks |
| Change in Plasma Choline | Change in plasma choline concentration. | Baseline and 8 weeks |
| Change in Dietary Intake | Assessment of changes in dietary intake, including total caloric intake, macronutrients, and micronutrients, using 24-hour dietary recalls. | Baseline, 4 weeks, and 8 weeks |
| Change in Physical Function Short Physical Performance Battery (SPPB) | Assessment of changes in physical function using the Short Physical Performance Battery (SPPB) with higher scores indicating better physical performance. | Baseline, 4 weeks, and 8 weeks |
| Change in Quality of Life (PROMIS) Questionnaires | Assessment of changes in their quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) instruments, including pain intensity and behavior, emotional, support, fatigue, physical function, sleep disturbance domains, and global health measures. "Never" indicates the worst score, with "Always" indicating a good score. | Baseline, 4 weeks, and 8 weeks |
| Change in Hand Grip Strength | Change in hand grip strength measured in kilograms using a dynamometer. | Baseline, 4 weeks, and Week 8 |
| Change in Body Weight | Body weight will be measured in kilograms using a calibrated scale. Change in body weight will be calculated as the difference between weight at baseline and weight at Week 8. Positive values indicate weight gain, while negative values indicate weight loss. | Baseline, 4 weeks, and 8 weeks |
| Change in Fat Mass (kg) measured by DXA | Fat mass will be assessed using the whole-body dual-energy X-ray absorptiometry (DXA). Change in fat mass will be calculated as the difference between baseline and Week 8 measurements, expressed in kilograms | Baseline and 8 weeks |
| Change in Body Mass Index | Body mass index (BMI) will be calculated from weight in kilograms divided by height in meters squared (kg/m²). Change in BMI will be calculated as the difference between BMI at baseline and BMI at Week 4 and Week 8. Positive values indicate an increase in BMI. | Baseline, Week 4, and Week 8 |
| Changes in Mid-Upper Arm Circumference (MUAC) | Mid-upper arm circumference will be measured in centimeters using a flexible measuring tape. Change will be calculated as the difference between measurements at baseline, Week 4, and Week 8. | baseline, Week 4, and Week 8. |
| Change in Skinfold Thickness | Skinfold thickness will be measured in millimeters using calibrated calipers at four standardized anatomical sites. Change will be calculated as the difference between measurements at baseline, Week 4, and Week 8. | baseline, Week 4, and Week 8. |
| Change in Lean Body Mass (kg) measured by DXA | Lean body mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA). Change in lean body mass will be calculated as the difference between baseline and Week 8 measurements, expressed in kilograms | Baseline and Week 8 |
| University of Pennsylvania Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| 32384122 | Result | 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. |
| 37671264 | Result | 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. |
| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |