Nutrition Intervention for Pancreatic Cancer
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
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
Treatments tested in this trial
- Structured Lipid Medical Food
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov