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)

Creators

Guangyu Ji, Department of Thoracic Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Hao Wang, Department of Thoracic Surgery, Zhongshan Hospital, Fudan University
Lijie Tan, Department of Thoracic Surgery, Zhongshan Hospital, Fudan University
Hecheng Li, Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Chun Chen, Department of Thoracic Surgery, Fujian Medical University Union Hospital
Xian Gong, Department of Thoracic Surgery, Fujian Medical University Union Hospital
Jinxian He, Department of Thoracic Surgery, the Affiliated Lihuili Hospital, Ningbo University
Zhigang Li, Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University
Jinyi Wang, Department of Thoracic Surgery, Shanghai East Hospital, Tongji University School of Medicine
Yongmei Shi, Department of Clinical Nutrition, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine
Weitian Wei, Department of Thoracic Oncological Surgery, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital
Dingpei Han, Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Su Yang, Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Mingsong Wang, Department of Thoracic Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Yajie Zhang, Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Weiyu Shen, Department of Thoracic Surgery, the Affiliated Lihuili Hospital, Ningbo University
Chengqiang Li, Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Yuqin Cao, Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Jian Li, Clinical Research Center, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine
Qixun Chen, Department of Thoracic Oncological Surgery, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital
Shengguang Zhao, Department of Radiotherapy, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine
Qianwen Jin, Department of Clinical Nutrition, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine
Yi He, Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University

Description

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 .

Publication Date

1-1-2022

Publisher

figshare Academic Research System

DOI

10.6084/m9.figshare.c.6044737.v1

Document Type

Data Set

Identifier

10.6084/m9.figshare.c.6044737.v1

Embargo Date

1-1-2022

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