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 c...
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BMJ Publishing Group
2023-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/4/e067990.full |
| _version_ | 1797848332271353856 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Li Zhang |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-09T18:25:48Z |
| format | Article |
| id | doaj.art-b6e8165d402c40e68747ea07859e455e |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T18:25:48Z |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj.art-b6e8165d402c40e68747ea07859e455e2023-04-11T21:30:06ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2022-067990Effects 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 trialLi Zhang0Wei Wei1Gang Li2Hao Xu3Jian Zhou4Yong Wu5Xinying Wang6Yuxiu Liu7Chao Jiang8Jun Qian9Zhiqiang Tian10Guoli Li11Mengjie Lu12Da Zhou13Xuejin Gao14Xiaosong Xiang15Zhiping Sun16Kui Yi17Junbo Zuo18Yugang Wu19Kaipeng Duan20Research Institute of General Surgery, Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, ChinaDepartment of Anesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, People`s Republic of China1 Center for Molecular Medicine, Children`s Hospital of Fudan University, National Children`s Medical Center, Shanghai, ChinaNational Research Center for Chinese Medicine Cardiology, Beijing, ChinaDepartment of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanghai Clinical Center for Diabetes, Shanghai Key Clinical Center for Metabolic Disease, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai, ChinaDepartment of General Surgery, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China2 Central South University School of Life Sciences, Changsha, Hunan, ChinaData and Statistics Division of Department of Critical Care Medicine, Jinling Hospital, Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of Ophthalmology and Vision Science, Eye & ENT Hospital, Shanghai Medical School, Fudan University, Shanghai, People`s Republic of ChinaDepartment of General Surgery, ChangZhou Second Hospital, the affiliated Hospital of Nanjing Medical University, Changzhou, Jiangsu, ChinaInstitute of Immunology, PLA, and3Institute of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, ChinaSchool of Public Health, Shanghai JiaoTong University School of Medicine, Shanghai, ChinaResearch Institute of General Surgery, Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, ChinaResearch Institute of General Surgery, Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, ChinaResearch Institute of General Surgery, Nanjing Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, ChinaDepartment of Clinical Nutrition, Affiliated Second Hospital, Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of Gastroenteropancreatic Surgery, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of General Surgery, Zhenjiang First People`s Hospital, Zhenjiang, Jiangsu, ChinaDepartment of General Surgery, The Third Affiliated Hospital of Soochow University and The First People’s Hospital of Changzhou, Changzhou, Jiangsu, ChinaDepartment of General Surgery, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaIntroduction 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.https://bmjopen.bmj.com/content/13/4/e067990.full |
| spellingShingle | 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 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 BMJ Open |
| 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 |
| url | https://bmjopen.bmj.com/content/13/4/e067990.full |
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