Nutrition Intervention for Pancreatic Cancer
Recruiting · NCT07554560 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital of Philadelphia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 1 US state.
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States
- University of Pennsylvania Abramson Cancer Center - Philadelphia, Pennsylvania, United States