Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Feasibility of Encala Intervention ( Enrollment Rate )
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Encala intervention
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.
干预措施: Structured Lipid Medical Food (Other)
结局指标
主要结局
Feasibility of Encala Intervention ( Enrollment Rate )
时间窗: From enrollment to end of intervention at 8 weeks
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.
Change in PROMIS Gastrointestinal Symptom Score
时间窗: Baseline to Week 8
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.
Feasibility of Encala Intervention ( Retention Rate )
时间窗: Baseline to Week 8
Retention rate is defined as the proportion of participants completing the study.
Feasibility of Encala Intervention ( Visit Completion)
时间窗: Baseline to Visit 8
Visit completion is defined as the proportion of scheduled visits completed
Feasibility of Encala Intervention ( Product Adherence )
时间窗: Baseline to Visit 8
Product adherence is defined as the proportion of prescribed doses consumed based on daily logs and returned product records.
次要结局
- Baseline Malabsorption Blood Test (MBT) Area Under the Curve(Baseline and Week 8)
- Change in Total Plasma Fatty Acid Concentration(Baseline, 4 weeks, and 8 weeks)
- Change in Serum Prealbumin(Baseline, 4 weeks, and 8 weeks)
- Change in Serum Vitamin A(Baseline, 4 weeks, and 8 weeks)
- Change in Plasma Choline(Baseline and 8 weeks)
- Change in Dietary Intake(Baseline, 4 weeks, and 8 weeks)
- Change in Physical Function Short Physical Performance Battery (SPPB)(Baseline, 4 weeks, and 8 weeks)
- Change in Quality of Life (PROMIS) Questionnaires(Baseline, 4 weeks, and 8 weeks)
- Change in Hand Grip Strength(Baseline, 4 weeks, and Week 8)
- Change in Body Weight(Baseline, 4 weeks, and 8 weeks)
- Change in Body Composition (DXA)(Baseline and 8 weeks)
- Changes in Mid-Upper Arm Circumference (MUAC)(baseline, Week 4, and Week 8.)
- Change in Body Mass Index(Baseline, Week 4, and Week 8)
- Change in Skinfold Thickness(baseline, Week 4, and Week 8.)