Enteral Nutrition To Improve Nutritional Status, Treatment Tolerance, And Outcomes In Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy (Ccrt): Results Of A Prospective, Randomized, Controlled, Multicenter Trial (Nct 02399306).

4033 Background: Patients with esophageal cancer undergoing CCRT are at high risk of malnutrition. The aim of this study was to investigate the influence of enteral nutrition on nutritional status, treatment tolerance and outcomes in esophageal cancer patients undergoing CCRT. Methods: Patients with inoperable esophageal cancer were randomly assigned (2:1 ratio) to the enteral nutrition group (EN group) or the control group. Patients in the EN group were supported with individual enteral nutrition intervention according to the nutritional status assessment results. The control group was treated with conventional diet guidance. The primary endpoint was the change in body weight from baseline after treatment. Secondary endpoints were nutrition related blood parameter changes, treatment tolerance and outcomes. Results: Between Mar. 2015 and Jan. 2017, 158 patients from ten hospitals were randomised into the EN group (n = 106) and the control group (n = 52). Following CCRT, patients in EN group lost only 0.72±3.27 kg of body weight compared with 2.10±2.89 kg in the control group (P < 0.001). Participants who received EN had less decline than controls in serum albumin (2.66±5.05 g/L and 4.75±4.94 g/L, P < 0.001) and hemoglobin (10.29±15.78 g/L and 18.48±14.66 g/L, P < 0.001). Grade 3/4 leukopenia in the control group was significantly more frequent than the EN group (33.3% vs. 20.0 %, P = 0.011). Patients supported on EN experienced greater chemoradiotherapy completion rates (92.5% vs. 67.3%, P = 0.001) and lower infection rates (18.8% vs 31.7%, P = 0.021). There was significant difference in tumor response between two groups (EN group: 81.1%, control group: 67.3%, P = 0.004). The 1- and 2-year OS rates in the EN group were significantly greater (89.6% and 75.4%, respectively) compared with the control group (78.5% and 57.9%, respectively). Conclusions: Enteral nutrition may be advantageous in patients with esophageal cancer undergoing CCRT by improving nutritional status, treatment tolerance and outcomes. Clinical trial information: NCT 02399306.