Cargando…
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
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10106032/ https://www.ncbi.nlm.nih.gov/pubmed/37041057 http://dx.doi.org/10.1136/bmjopen-2022-067990 |
_version_ | 1785026335362514944 |
---|---|
author | Zhou, Da Liu, Yuxiu Zhang, Li Lu, Mengjie Gao, Xuejin Li, Guoli Xiang, Xiaosong Xu, Hao Li, Gang Sun, Zhiping Wei, Wei Yi, Kui Zuo, Junbo Wu, Yugang Qian, Jun Zhou, Jian Duan, Kaipeng Wu, Yong Tian, Zhiqiang Jiang, Chao Wang, Xinying |
author_facet | Zhou, Da Liu, Yuxiu Zhang, Li Lu, Mengjie Gao, Xuejin Li, Guoli Xiang, Xiaosong Xu, Hao Li, Gang Sun, Zhiping Wei, Wei Yi, Kui Zuo, Junbo Wu, Yugang Qian, Jun Zhou, Jian Duan, Kaipeng Wu, Yong Tian, Zhiqiang Jiang, Chao Wang, Xinying |
author_sort | Zhou, Da |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10106032 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-101060322023-04-17 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 Zhou, Da Liu, Yuxiu Zhang, Li Lu, Mengjie Gao, Xuejin Li, Guoli Xiang, Xiaosong Xu, Hao Li, Gang Sun, Zhiping Wei, Wei Yi, Kui Zuo, Junbo Wu, Yugang Qian, Jun Zhou, Jian Duan, Kaipeng Wu, Yong Tian, Zhiqiang Jiang, Chao Wang, Xinying BMJ Open Nutrition and Metabolism 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. BMJ Publishing Group 2023-04-11 /pmc/articles/PMC10106032/ /pubmed/37041057 http://dx.doi.org/10.1136/bmjopen-2022-067990 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Nutrition and Metabolism Zhou, Da Liu, Yuxiu Zhang, Li Lu, Mengjie Gao, Xuejin Li, Guoli Xiang, Xiaosong Xu, Hao Li, Gang Sun, Zhiping Wei, Wei Yi, Kui Zuo, Junbo Wu, Yugang Qian, Jun Zhou, Jian Duan, Kaipeng Wu, Yong Tian, Zhiqiang Jiang, Chao Wang, Xinying 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Nutrition and Metabolism |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10106032/ https://www.ncbi.nlm.nih.gov/pubmed/37041057 http://dx.doi.org/10.1136/bmjopen-2022-067990 |
work_keys_str_mv | AT zhouda effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT liuyuxiu effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT zhangli effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT lumengjie effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT gaoxuejin effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT liguoli effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT xiangxiaosong effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT xuhao effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT ligang effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT sunzhiping effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT weiwei effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT yikui effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT zuojunbo effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT wuyugang effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT qianjun effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT zhoujian effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT duankaipeng effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT wuyong effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT tianzhiqiang effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT jiangchao effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial AT wangxinying effectsoforalimmunonutritionalsupplementon3yeardiseasefreesurvivalingastriccancerpatientswithpathologicalstageiiiaftertotalgastrectomycrucialstudyprotocolofamulticentrerandomisedclinicaltrial |