Health TrialsbyHealthPanel

Nutrition Intervention for Pancreatic Cancer

ConditionsPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Neuroendocrine Tumor (NET)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChildren's Hospital of Philadelphia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Structured Lipid Medical Food

    Other intervention

    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.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Encala interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
Baseline to Week 8
3

Feasibility of Encala Intervention ( Retention Rate )

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

Time frame
Baseline to Week 8
4

Feasibility of Encala Intervention ( Visit Completion)

Visit completion is defined as the proportion of scheduled visits completed

Time frame
Baseline to Visit 8

Secondary outcomes

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.

Time frame
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.

Time frame
Baseline, 4 weeks, and 8 weeks
3

Change in Serum Prealbumin

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

Time frame
Baseline, 4 weeks, and 8 weeks
4

Change in Serum Vitamin A

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

Time frame
Baseline, 4 weeks, and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

University of Pennsylvania

Collaborator

Source ClinicalTrials.gov
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