Nutrition Intervention for Pancreatic Cancer

May 1, 2026 updated by: Children's Hospital of Philadelphia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Virginia Stallings, MD
        • Principal Investigator:
          • Jefferson N Brownell, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Abramson Cancer Center
        • Contact:
        • Sub-Investigator:
          • Ursina R Teitelbaum, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Structured 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.
Other Names:
  • Encala

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to end of intervention at 8 weeks
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.
Baseline to Week 8
Feasibility of Encala Intervention ( Retention Rate )
Time Frame: Baseline to Week 8
Retention rate is defined as the proportion of participants completing the study.
Baseline to Week 8
Feasibility of Encala Intervention ( Visit Completion)
Time Frame: Baseline to Visit 8
Visit completion is defined as the proportion of scheduled visits completed
Baseline to Visit 8
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.
Baseline to Visit 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 8
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.
Baseline, 4 weeks, and 8 weeks
Change in Serum Prealbumin
Time Frame: Baseline, 4 weeks, and 8 weeks
Change in serum prealbumin concentration as a marker of nutritional status.
Baseline, 4 weeks, and 8 weeks
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
Baseline, 4 weeks, and 8 weeks
Change in Plasma Choline
Time Frame: Baseline and 8 weeks
Change in plasma choline concentration.
Baseline and 8 weeks
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.
Baseline, 4 weeks, and 8 weeks
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.
Baseline, 4 weeks, and 8 weeks
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.
Baseline, 4 weeks, and 8 weeks
Change in Hand Grip Strength
Time Frame: Baseline, 4 weeks, and Week 8
Change in hand grip strength measured in kilograms using a dynamometer.
Baseline, 4 weeks, and Week 8
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.
Baseline, 4 weeks, and 8 weeks
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.
baseline, Week 4, and Week 8.
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
Baseline and 8 weeks
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.
Baseline, Week 4, and Week 8
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.
baseline, Week 4, and Week 8.
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
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania

Investigators

  • Principal Investigator: Virginia A Stallings, MD, Children's Hospital of Philadelphia
  • Principal Investigator: Jefferson N Brownell, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-023423
  • HT94252510749 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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