A prospective trial of elemental enteral feeding in patients with pancreatic cancer cachexia (PANCAX-1).

Abstract

726 Background: Unintentional weight loss affecting > 85% of pancreatic cancer (PC) patients contributes to low therapeutic tolerance, reduced quality of life, and overall mortality. Optimal treatment approaches have not been developed. We hypothesize that peptide-based enteral nutritional support in cachectic advanced PC patients, receiving palliative chemotherapy, results in improved weight, lean body mass (LBM), and hand-grip strength. Methods: Pancreatic adenocarcinoma patients with cachexia (> 5% unintentional weight loss within the previous 6 months) were provided a jejunal tube peptide-based diet for 3 months. Primary outcome was weight stability (0.1kg/BMI unit decrease). Secondary outcomes included changes from baseline in LBM, bone mineral density (BMD), total body fat mass (BFM), handgrip strength, physical activity (Fitbit), and CA19-9 and CRP. Planned interim analysis was performed after 14 patients completed treatment. Results: From 31 consenting patients, 16 were evaluable for the primary outcome. Patients receiving enteral therapy were 39% male, median age 69 (Range: 41 to 89 years), and 74% ECOG 1. A summary of change in outcomes at 3 months from baseline is shown in Table. The primary endpoint of weight stability in 10 (62.5%) patients was met, thus completing study. Overall survival was 6.5 months (n=31) and 9.9 months for evaluable patients (n=16). Weight stability was statistically associated with LBM (Pearson’s correlation: 0.87, p<0.001), but not survival (HR: 0.94, 95% CI 0.32, 2.83, p=0.92). Conclusions: Peptide-based enteral feeding resulted in weight stability and improvements in lean body mass and physical function. Further randomized trials assessing nutritional support in advanced patients are warranted. NIH/NCATS Grant # UL1TR000124. Clinical trial information: NCT02400398 . [Table: see text]