Evaluation of the effects of postoperative oral nutrition support on body weight in gastric cancer patients by using an elemental diet: A randomized study.

Abstract

110 Background: Postoperative weight loss causes deterioration in the patient’s quality of life and influences long-term prognosis in gastric cancer patients who have undergone gastrectomy. Moreover, recent retrospective studies indicated postoperative weight loss as a risk factor for premature interruption of S-1 adjuvant chemotherapy. We conducted a prospective randomized controlled study to examine whether the early institution of nutritional support comprising an oral elemental diet (ED) prepared for post-gastrectomy patients with depressed digestive/absorptive function would help prevent postoperative weight loss. Methods: After surgery, patients were randomly assigned to the ED or control groups. The groups were divided according to the surgical methods used (total/distal gastrectomy), clinical stage (≤Ia/>Ia), and patients’ body mass index (<18.5/>18.5). In patients assigned to the ED group (Elental, 300 kcal) was provided in addition to the regular diet from the day starting soft rice diet or equivalent diet to 6–8 weeks after surgery. The primary endpoint was the percentage of body weight change from the pre-surgical body weight to that at 6–8 weeks after surgery. The secondary endpoints were ED adherence, nutrition-related blood parameter changes, and adverse effects. Results: The study included 112 patients from eight hospitals. There was a significant difference in the percentage of body weight loss (%BWL) between the ED and control groups (4.88±3.41% and 6.91±5.06%; P=0.015). Sub-group analysis showed a significant difference in the %BWL in patients who underwent total gastrectomy (5.31±3.43% and 9.11±5.57%; P=0.016). Multivariate analysis demonstrated ED treatment and surgery type as independent factors that affect body weight changes. The mean treatment compliance rate in the 58 ED-group patients was 72.9±33.1%, with a favorable median value of 90.8%. No significant differences were observed in any parameter analyzed, including hematological and non-hematological adverse events, between the two groups. Conclusions: The ED product can prevent postoperative weight loss in gastric cancer patients undergoing gastrectomy. Clinical trial information: 000008056.