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Pancreatic Ductal Adenocarcinoma (PDAC)NCT07554560

Nutrition Intervention for Pancreatic Cancer

A study testing Structured Lipid Medical Food in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Pancreatic Neuroendocrine Tumor (NET), run by Children's Hospital of Philadelphia at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Structured Lipid Medical Food
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesUnited States
Study dates
7 Apr 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Edmond K Appiah, MPH contact

267-426-9381

appiahe@chop.edu

United States2 sites, 2 recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Edmond K Appiah, MPH, 267-426-9381, appiahe@chop.edu

    Virginia Stallings, MD

    Recruiting

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Edmond K Appiah, MPH, 267-426-9381, appiahe@chop.edu

    Ursina R Teitelbaum, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Structured Lipid Medical Food
Keywords
Pancreatic Ductal Adenocarcinoma, Pancreatic Neuroendocrine Tumor, Exocrine pancreatic insufficiency, Fat malabsorption, Quality of life, Gastrointestinal symptoms
Medical subject headings
Adenoma, Islet Cell, Exocrine Pancreatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Lipid Medical FoodOther

    Also called Encala

    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.

Study groups in NCT07554560
Study groupRoleWhat they receive
Encala interventionExperimentalParticipants 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.
Receives: Other: Structured Lipid Medical Food

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to end of intervention at 8 weeks

  2. 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.

    Measured: Baseline to Week 8

  3. Feasibility of Encala Intervention ( Retention Rate )

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

    Measured: Baseline to Week 8

  4. Feasibility of Encala Intervention ( Visit Completion)

    Visit completion is defined as the proportion of scheduled visits completed

    Measured: Baseline to Visit 8

  5. 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.

    Measured: Baseline to Visit 8

Secondary outcomes (15)

  1. 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.

    Measured: Baseline and Week 8

  2. Change in Total Plasma Fatty Acid Concentration

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

    Measured: Baseline, 4 weeks, and 8 weeks

  3. Change in Serum Prealbumin

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

    Measured: Baseline, 4 weeks, and 8 weeks

  4. Change in Serum Vitamin A

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

    Measured: Baseline, 4 weeks, and 8 weeks

  5. Change in Plasma Choline

    Change in plasma choline concentration.

    Measured: Baseline and 8 weeks

  6. Change in Dietary Intake

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

    Measured: Baseline, 4 weeks, and 8 weeks

  7. 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.

    Measured: Baseline, 4 weeks, and 8 weeks

  8. 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.

    Measured: Baseline, 4 weeks, and 8 weeks

  9. Change in Hand Grip Strength

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

    Measured: Baseline, 4 weeks, and Week 8

  10. 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.

    Measured: Baseline, 4 weeks, and 8 weeks

  11. 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

    Measured: Baseline and 8 weeks

  12. 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.

    Measured: Baseline, Week 4, and Week 8

  13. 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.

    Measured: baseline, Week 4, and Week 8.

  14. 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.

    Measured: baseline, Week 4, and Week 8.

  15. 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

    Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2026
  2. Study start7 Apr 2026
  3. Primary completionApr 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07554560
Sponsor's protocol ID
25-023423
Other IDs
HT94252510749
Status last verified
May 2026
First submitted
17 Apr 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 25689042

  • 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.

    PubMed 27050056

  • 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.

    PubMed 32384122

  • 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.

    PubMed 37671264

Questions about this trial

What is this clinical trial studying?

A study testing Structured Lipid Medical Food in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Pancreatic Neuroendocrine Tumor (NET), run by Children's Hospital of Philadelphia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edmond K Appiah, MPH (267-426-9381, appiahe@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Encala Intervention ( Enrollment Rate ) (time frame: From enrollment to end of intervention at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07554560, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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