Efficacy of Simple Oral Nutritional Supplements versus Usual Care in Postoperative Patients with Gastric Cancer: A Multicenter, Open-label, Parallel, Randomized Controlled Trial.

Abstract

To evaluate the efficacy of a simple oral nutritional supplement (ONS) without excess nutrients on body weight loss (BWL) after gastrectomy in patients with gastric cancer. BWL is commonly observed in the early few months after gastrectomy for gastric cancer. It is uncertain if a simple ONS with usual diet improve postoperative BWL. A multicenter randomized controlled trial was conducted across 19 institutions. Patients undergoing curative gastrectomy for gastric cancer were randomized into the ONS or control group. The ONS group received 400 mL (kcal)/day of ONS mainly containing carbohydrates and proteins for 8 weeks postoperatively. The primary endpoint was the percentage of BWL from baseline to postoperative 8 weeks. Secondary endpoints included handgrip strength, hematological parameters, health-related quality of life, dietary intake, and ONS adherence. The 124 patients were randomized to the ONS group (n=62) or control group (n=62), with 2 in the ONS group lost to follow-up. The ONS group experienced significantly less weight loss at postoperative 8 weeks (-4.8% vs. -6.4%, P=0.039). No significant differences were observed in handgrip strength or hematological parameters. The incidences of adverse events were comparable between the groups (7% vs. 11%, P=0.373), but the ONS group had higher symptom scores for insomnia, appetite loss, and diarrhea during intervention. The mean ONS intake was >75% (308.7 mL±97.0 mL/d). The simple ONS for 8 weeks after gastrectomy reduced postoperative BWL in patients with gastric cancer.