This early phase I trial tests the effect of a structured lipid medical food (SLMF) product on gastrointestinal (GI) function and quality of life in patients with pancreatic neuroendocrine tumors (NET) or pancreatic ductal adenocarcinoma (PDAC). Patients with pancreatic cancer often have difficulty absorbing fat, which can lead to stomach pain, bloating, and diarrhea. The current standard treatment for pancreatic cancer patients with GI symptoms and weight loss may include pancreatic enzyme replacement therapy and recommendations to consume meals and snacks to decrease weight loss. SLMF is a nutrition supplement product designed using a healthy plant-based fat compound that helps the body absorb fat more easily, even when normal digestion is affected. Taking SLMF may improve GI function and overall well-being for patients with pancreatic NET or PDAC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07554560.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Jefferson N. Brownell
Phone: 267-425-1628
PRIMARY OBJECTIVE:
I. To assess the feasibility, tolerability, and safety of administering a structured lipid medical food (SLMF) powder to participants with PDAC and NET who are at high risk for exocrine pancreatic insufficiency (EPI), fat malabsorption, GI dysfunction, and weight loss.
SECONDARY OBJECTIVES:
I. To characterize baseline fat malabsorption status using the Malabsorption Blood Test (MBT) and explore changes in plasma fatty acid profiles following 8 weeks of SLMF supplementation.
II. To explore changes in nutritional status, body composition, and physical function following SLMF supplementation.
III. To explore changes in dietary intake patterns and quality of life following SLMF supplementation.
OUTLINE:
Patients receive the SLMF product orally (PO) 4-5 times daily for 8 weeks. Patients also receive nutrition education and recipes on study. Additionally, patients undergo blood sample collection and dual energy x-ray absorptiometry (DXA) scans throughout the study.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorJefferson N. Brownell