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NCT Number: NCT07554560

Nutrition Intervention for Pancreatic Cancer

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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC) Adenoma Adenoma, Islet Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Exocrine Pancreatic Insufficiency Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Pancreatic Neuroendocrine Tumor (NET)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Encala

Primary outcomes

  1. Feasibility of Encala Intervention ( Enrollment Rate )

    Time frame: 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.

  2. Change in PROMIS Gastrointestinal Symptom Score

    Time frame: 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.

  3. Feasibility of Encala Intervention ( Retention Rate )

    Time frame: Baseline to Week 8

    Retention rate is defined as the proportion of participants completing the study.

  4. Feasibility of Encala Intervention ( Visit Completion)

    Time frame: Baseline to Visit 8

    Visit completion is defined as the proportion of scheduled visits completed

  5. Feasibility of Encala Intervention ( Product Adherence )

    Time frame: Baseline to Visit 8

    Product adherence is defined as the proportion of prescribed doses consumed based on daily logs and returned product records.

Secondary outcomes

  1. Baseline Malabsorption Blood Test (MBT) Area Under the Curve

    Time frame: Baseline and Week 8

    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.

  2. Change in Total Plasma Fatty Acid Concentration

    Time frame: Baseline, 4 weeks, and 8 weeks

    Change in total plasma fatty acid concentration as a measure of dietary fat absorption.

  3. Change in Serum Prealbumin

    Time frame: Baseline, 4 weeks, and 8 weeks

    Change in serum prealbumin concentration as a marker of nutritional status.

  4. Change in Serum Vitamin A

    Time frame: Baseline, 4 weeks, and 8 weeks

    Change in serum vitamin A concentration as a marker of nutritional status

  5. Change in Plasma Choline

    Time frame: Baseline and 8 weeks

    Change in plasma choline concentration.

  6. Change in Dietary Intake

    Time frame: Baseline, 4 weeks, and 8 weeks

    Assessment of changes in dietary intake, including total caloric intake, macronutrients, and micronutrients, using 24-hour dietary recalls.

  7. Change in Physical Function Short Physical Performance Battery (SPPB)

    Time frame: Baseline, 4 weeks, and 8 weeks

    Assessment of changes in physical function using the Short Physical Performance Battery (SPPB) with higher scores indicating better physical performance.

  8. Change in Quality of Life (PROMIS) Questionnaires

    Time frame: Baseline, 4 weeks, and 8 weeks

    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.

  9. Change in Hand Grip Strength

    Time frame: Baseline, 4 weeks, and Week 8

    Change in hand grip strength measured in kilograms using a dynamometer.

  10. Change in Body Weight

    Time frame: Baseline, 4 weeks, and 8 weeks

    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.

  11. Change in Fat Mass (kg) measured by DXA

    Time frame: Baseline and 8 weeks

    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

  12. Change in Body Mass Index

    Time frame: Baseline, Week 4, and Week 8

    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.

  13. Changes in Mid-Upper Arm Circumference (MUAC)

    Time frame: baseline, Week 4, and Week 8.

    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.

  14. Change in Skinfold Thickness

    Time frame: baseline, Week 4, and Week 8.

    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.

  15. Change in Lean Body Mass (kg) measured by DXA

    Time frame: Baseline and Week 8

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Edmond K Appiah, MPH

CONTACT

[email protected]

267-426-9381

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • University of Pennsylvania

Registry information

Official study title

Feasibility, Tolerance, and Fat Metabolism Pilot Study of a Structured Lipid Medical Food in Patients With Pancreatic Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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