Effects of oral immunonutritional supplement on 3-year disease-free survival in gastric cancer patients with pathological stage III after total gastrectomy (CRUCIAL): study protocol of a multicentre, randomised clinical trial
Li Zhang,
Wei Wei,
Gang Li,
Hao Xu,
Jian Zhou,
Yong Wu,
Xinying Wang,
Yuxiu Liu,
Chao Jiang,
Jun Qian,
Zhiqiang Tian,
Guoli Li,
Mengjie Lu,
Da Zhou,
Xuejin Gao,
Xiaosong Xiang,
Zhiping Sun,
Kui Yi,
Junbo Zuo,
Yugang Wu,
Kaipeng Duan
Affiliations
Li Zhang
School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, State Key Laboratory of Respiratory Health and Multimorbidity, Key Laboratory of Pathogen Infection Prevention and Control (Peking Union Medical College), Ministry of Education, Beijing, China
Wei Wei
Department of Laboratory Medicine, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Gang Li
Department of Neurology, Shanghai East Hospital, Tongji University, Shanghai, China
Hao Xu
Genentech Inc, South San Francisco, California, USA
Jian Zhou
2 Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China
Yong Wu
Department of Oncology, the Second Affiliated Hospital, School of Medicine, South China University of Technology, Guangzhou, China
Xinying Wang
University of South China School of Nursing, Hengyang, Hunan, China
Yuxiu Liu
Data and Statistics Division of Department of Critical Care Medicine, Nanjing Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China
Chao Jiang
Department of General Surgery, Yixing People`s Hospital, Yixing, Jiangsu, China
Jun Qian
Department of General Surgery, ChangZhou Second Hospital, the affiliated Hospital of Nanjing Medical University, Changzhou, Jiangsu, China
Zhiqiang Tian
Department of General Surgery, Wuxi People’s Hospital Affiliated to Nanjing Medical University, Wuxi, Jiangsu, China
Guoli Li
Research Institute of General Surgery, Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, China
Mengjie Lu
China Hospital Development Institute, School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Da Zhou
Health Commission of Hubei Province, Wuhan, Hubei, China
Xuejin Gao
Research Institute of General Surgery, Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, China
Xiaosong Xiang
Research Institute of General Surgery, Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, China
Zhiping Sun
Department of Clinical Nutrition, Affiliated Second Hospital, Nanjing Medical University, Nanjing, Jiangsu, China
Kui Yi
Department of Gastroenteropancreatic Surgery, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
Junbo Zuo
Department of General Surgery, Zhenjiang First People`s Hospital, Zhenjiang, Jiangsu, China
Yugang Wu
Department of General Surgery, The Third Affiliated Hospital of Soochow University and The First People’s Hospital of Changzhou, Changzhou, Jiangsu, China
Kaipeng Duan
Department of General Surgery, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Introduction The nutritional status of patients with gastric cancer (GC) after total gastrectomy continues to deteriorate and lasts a long time after discharge, which is an independent risk factor for mortality. Recent guidelines have recommended appropriate nutritional support after discharge for cancer surgery patients with malnutrition or nutritional risk. The evidence on the efficacy of oral immunonutritional supplement (INS) and its effect on long-term disease-free survival (DFS) in patients with GC is limited. This study was designed to test the hypothesis that oral INS compared to diet alone may improve 3-year DFS of GC patients with pathological stage III after total gastrectomy (Nutrition Risk Screening 2002 score ≥3 at discharge).Methods and analysis This is a pragmatic, open-label, multicentre, randomised controlled study. 696 eligible GC patients with pathological stage III after total gastrectomy will be randomised in a 1:1 ratio to oral INS group or normal diet group for 6 months. The primary endpoint is 3-year DFS after discharge. The following secondary endpoints will be evaluated: 3-year overall survival; unplanned readmission rate at 3 and 6 months after discharge; quality of life, body mass index and haematological index at 3, 6 and 12 months after discharge; incidence of sarcopenia at 6 and 12 months after discharge; and the tolerance to chemotherapy. The adverse events of oral INS will also be evaluated during the intervention.Ethics and dissemination This study was approved by the ethics committee of Jinling Hospital, Nanjing University (number 2021NZKY-069-01). The present study may validate the effectiveness of oral immunonutritional therapy in improving 3-year DFS for GC patients with pathological stage III after total gastrectomy for the first time. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration number NCT05253716.
