UPCC 02226 Feasibility, Tolerance and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients with Pancreatic Cancer
Structured Lipid Medical Food for Pancreatic Cancer
Brief description of study
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 of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Neuroendocrine Tumor (NET)
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Age: 18 years or above
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Gender: All
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
This study investigates pancreatic cancer. It focuses on a structured lipid medical food designed to address fat malabsorption in patients who have difficulty absorbing fats due to their condition.
The purpose of this study is to evaluate the safety, tolerance, and potential effects of the structured lipid medical food. It looks at how this food might improve fat absorption and provide nutritional support for those with pancreatic cancer.
- Who can participate: Adults 18 years and older with pancreatic ductal adenocarcinoma or pancreatic neuroendocrine tumors may participate. Key factors include a life expectancy of 4 months or more and receiving most daily calories through oral or enteral feeding.
- Study details: Participants will consume the structured lipid medical food daily for 8 weeks. The study will assess changes in symptoms and nutritional status. An inactive substance, called a placebo, is not used in this study.
- Study timelines and visits: The study will last 8 weeks. The study requires 3 visits.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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