A randomized controlled trial of oral nutritional supplementation versus standard diet following McKeown minimally invasive esophagectomy in patients with esophageal malignancy: a pilot study

BACKGROUND: Body weight loss (BWL) following esophagectomy is a common complication in esophageal cancer (EC) which represents a deterioration in quality of life (QoL) and poor long-term prognosis. A pilot randomized controlled study was initiated to evaluate the feasibility, safety, and efficacy of a short‐term oral nutritional supplementation (ONS) on postoperative BWL and QoL in patients undergoing esophagectomy. METHODS: Patients enrolled in this study were randomly divided into two different groups: the intervention group which received oral nutritional intervention (300 mL/day for 4 weeks) and the control group which received standard diet alone. Participants were assessed at discharge and 1, 3, and 6 months following discharge for BWL and QoL. At the same time, the data of clinical baseline characteristics, nutrition-related complications, and feasibility were prospectively collected and analyzed. RESULTS: A total of 77 patients were enrolled in this study. However, owing to severe postoperative complications and discontinuation of the program, 33 participants in the ONS group and 31 participants in the control group were eligible for final analysis of body weight change and QoL. Significant differences in percentage of BWL (%BWL) between the two groups were discovered at 3 and 6 months follow-up: participants in the ONS group had lower %BWL than those in the control group (P=0.024; P=0.025, respectively). There were significant differences in body mass index (BMI) loss between the two groups. At 1 month, QoL was significantly improved in the ONS group (P=0.031); however, no differences of QoL were noticed at 3 and 6 months. Compared with the control group, ONS improved the physical function and role function and eased the symptom of fatigue (P=0.014, P=0.030, and P=0.008, respectively). It was also noted that ONS increased the nutrition-related complications compared to the standard diet (50% vs. 42.9%), although the difference was not statistically significant (P=0.647). CONCLUSIONS: This pilot study indicated that addition of ONS was feasible, safe, and might prevent the loss of body weight and BMI and have a positive impact on the QoL in esophagectomy patients. The effectiveness of ONS requires further confirmation in an appropriately powered study. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100045303.