Effectiveness of an Oral Elemental Diet for Patients With Unresectable Pancreatic Cancer: a Prospective Cohort Study

Abstract Objectives: Advanced pancreatic cancer (PC) causes nutritional deterioration and weight loss due to a decrease in digestive and absorption capacity associated with exocrine pancreatic insufficiency. Therefore, we conducted a prospective cohort study to evaluate the effectiveness of an elemental diet (ED).Methods: We conducted a two-centers, prospective consecutive observational study to assess the outcomes of patients with unresectable PC who underwent first-line chemotherapy. We enrolled patients receiving chemotherapy for unresectable PC from January 2017 to December 2019 and prescribed an oral ED (ED group). From December 2014 to December 2016, 43 patients before the introduction of ED therapy in our institutions were retrospectively studied as a historical cohort. Data on the nutritional markers at baseline and 3 months were extracted, and serial changes were compared between the 2 groups.Results: A comparison of the background of the two groups revealed that the clinical stage was significantly worse and serum CA19-9 levels were significantly higher in the ED group. The serial changes at 3 months in body mass index, serum CEA, and serum CA19-9 were not statistically significant. The serum albumin level tended to show a much greater decrease in the historical cohort (P=0.15). Furthermore, the serum total protein level and prognostic nutrition index were significantly decreased in the historical cohort (P=0.02, <0.005, respectively). Conclusions: This prospective study demonstrated that ED tended to improve the nutritional status during chemotherapy for unresectable PC.Trial registration number and date of registration: UMIN Clinical Trials Registry (UMIN-CTR: 000025967), February 2, 2017.