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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...

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Autores principales: 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
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
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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.
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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
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