Nutrition Intervention for Pancreatic Cancer

NCT07554560 | Recruiting DMC

• 2 other identifiers: 25-023423HT94252510749
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Neuroendocrine Tumor (NET)

Keywords

Pancreatic Ductal Adenocarcinoma; Pancreatic Neuroendocrine Tumor; Exocrine pancreatic insufficiency; Fat malabsorption; Quality of life; Gastrointestinal symptoms

Outcome Measures

Primary Outcomes (5)

• 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.

  From enrollment to end of intervention at 8 weeks

• 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.

  Baseline to Week 8

• Feasibility of Encala Intervention ( Retention Rate )

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

  Baseline to Week 8

• Feasibility of Encala Intervention ( Visit Completion)

  Visit completion is defined as the proportion of scheduled visits completed

  Baseline to Visit 8

• 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.

  Baseline to Visit 8

Secondary Outcomes (15)

• 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

Study Arms (1)

Encala intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: Encala

Encala intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 25689042 RESULT

• 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.

  PMID: 27050056 RESULT

• 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.

  PMID: 32384122 RESULT

• 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.

  PMID: 37671264 RESULT

MeSH Terms

Conditions

Adenoma, Islet Cell; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Virginia A Stallings, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Jefferson N Brownell, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edmond K Appiah, MPH

CONTACT

267-426-9381; appiahe@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 28, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)