Effects of pre-operative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy: protocol for a multicenter randomized controlled trial (point trial, pre-operative immunonutrition therapy)

Abstract

Background Neoadjuvant chemoradiation followed by esophagectomy has been established as the first-line treatment for locally advanced esophageal cancer. Postoperative enteral nutrition has been widely used to improve perioperative outcomes. However, whether to implement preoperative nutritional intervention during neoadjuvant therapy is yet to be verified by prospective studies. Methods POINT trial is a multicenter, open-labeled, randomized controlled trial. A total of 244 patients with surgically resectable esophageal cancer are randomly assigned to nutritional therapy group (arm A) or control group (arm B) with a 2:1 ratio. Both groups receive neoadjuvant chemotherapy with concurrent radiotherapy based on the CROSS regimen followed by minimally invasive esophagectomy. The primary endpoint is the rate of nutrition and immune-related complications after surgery. Secondary endpoints include completion rate of neoadjuvant chemoradiation and related adverse events, rate of pathological complete response, perioperative outcomes, nutritional status, overall survival, progression-free survival and quality of life. Discussion This trial aims to verify whether immunonutrition during neoadjuvant chemoradiation can reduce the rate of complications and improve perioperative outcomes. Frequent communication and monitoring are essential for a multicenter investigator-initiated trial. Trial registration: ClinicalTrials.gov: NCT04513418. The trial was prospectively registered on 14 August 2020, https://www.clinicaltrials.gov/ct2/show/NCT04513418.

Case report: Nutritionally supported perioperative chemo-immunotherapy for advanced gastric cancer with incomplete pyloric obstruction

“…However, the specific role of nutritional support therapy in the treatment of gastric cancer is still being explored. At the same time, the oral intake and tolerance with enteral nutritional may vary with the progression of disease ( 18 ). Therefore, more research and evidence are needed to confirm if this nutritional regimen can be applied to more patients.…”

Does enteral immune nutrition (EIN) boost the immunity of gastric cancer (GC) patients undergoing surgery? A systematic review and meta-analysis.

“…As shown in Figure 7 , EIN is an enteral feeding formula made up of nutritional supplements such as amino acids arginine and/or glutamine, omega-3 predominant marine oils, nucleic acids, antioxidants, vitamins, and minerals [ 48 ]. These supplements are used because amino acids cause immune cell activation by improving cell metabolic reprogramming via receptor ligation and by enhancing the rate of transcription and translation [ 49 ].…”

Online tools to predict individualised survival for primary oesophageal cancer patients with and without pathological complete response after neoadjuvant therapy followed by oesophagectomy: development and external validation of two independent nomograms

“…External validation used an independent dataset consisting of prospectively collected cases from four multicentre clinical trials conducted in China (NCT03792347,7 NCT04435197,31 NCT0451341832 and NCT0300159614 15 33) and retrospective data of patients diagnosed between 2013 and 2022 at Shanghai Ruijin Hospital. A total of 444 patients were included, 92 (20.7%) of whom achieved pCR (online supplemental eFigure 2).…”