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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Jiangsu Cancer Institute & Hospital | OTHER |
| Nanjing Jiangning Hospital | UNKNOWN |
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Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected.
Gastric cancer patients with stage III after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to immune nutrition support (INS) or control (C) group after discharge. In the INS group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil lasted for 6 months. In the C group, patients will receive normal diet. Both groups will receive nutrition counseling.
The primary and secondary outcomes will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immune nutrition support | Experimental | In the immune nutrition support group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil after discharge lasted for 6 months. |
|
| control | No Intervention | In the control group, patients will receive nutrition counseling in addition to diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONS | Other | Immunonutritional supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival after discharge | from date of randomization to disease recurrence or death | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival | from date of randomization to death due to any reason, | up to 3 years. |
| unplanned readmission rate | readmission due to unplanned reason |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingting Gao, MS | Contact | 15312311968 | gaotting77@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinying Wang, MD | Jinling Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital, China | Recruiting | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26583669 | Background | Heneghan HM, Zaborowski A, Fanning M, McHugh A, Doyle S, Moore J, Ravi N, Reynolds JV. Prospective Study of Malabsorption and Malnutrition After Esophageal and Gastric Cancer Surgery. Ann Surg. 2015 Nov;262(5):803-7; discussion 807-8. doi: 10.1097/SLA.0000000000001445. | |
| 32913478 | Background | Huang DD, Cai HY, Chen XY, Dong WX, Wangchuk D, Yan JY, Chen XL, Dong QT. Value of Sarcopenia defined by the new EWGSOP2 consensus for the prediction of Postoperative Complications and Long-term Survival after Radical Gastrectomy for Gastric Cancer: A comparison with four common nutritional screening tools. J Cancer. 2020 Aug 6;11(19):5852-5860. doi: 10.7150/jca.49815. eCollection 2020. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
Not provided
Not provided
| Zhenjiang First People's Hospital |
| OTHER |
| The Third Affiliated Hospital of Soochow University | OTHER |
| ChangZhou Second hospital | UNKNOWN |
| The First Affiliated Hospital of Soochow University | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| Yixing People's Hospital | OTHER |
| The Second Hospital of Nanjing Medical University | OTHER |
| Wuxi People's Hospital | OTHER |
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| up to 6 months. |
| Quality of life after discharge | Quality of life assessed by EORTC QLQ-C30 | up to 12 months. |
| incidence of sarcopenia after discharge | sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability. | up to 12 months. |
| Changes in BMI (weight and height will be combined to report BMI in kg/m^2) | nutritional status after discharge | up to 12 months. |
| Changes in albumin level | nutritional status after discharge | up to 12 months. |
| Changes in prealbumin level | nutritional status after discharge | up to 12 months. |
| Changes in hemoglobin level | nutritional status after discharge | up to 12 months. |
| Changes in weight | nutritional status after discharge | up to 12 months. |
| toxicity of chemotherapy graded according to the CTCAE, version 5.0 | Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0. | up to 6 months. |
| 28699132 | Background | Zheng HL, Lu J, Li P, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu R, Huang CM, Zheng CH. Effects of Preoperative Malnutrition on Short- and Long-Term Outcomes of Patients with Gastric Cancer: Can We Do Better? Ann Surg Oncol. 2017 Oct;24(11):3376-3385. doi: 10.1245/s10434-017-5998-9. Epub 2017 Jul 11. |
| 28477106 | Background | Ongaro E, Buoro V, Cinausero M, Caccialanza R, Turri A, Fanotto V, Basile D, Vitale MG, Ermacora P, Cardellino GG, Nicoletti L, Fornaro L, Casadei-Gardini A, Aprile G. Sarcopenia in gastric cancer: when the loss costs too much. Gastric Cancer. 2017 Jul;20(4):563-572. doi: 10.1007/s10120-017-0722-9. Epub 2017 May 5. |
| 33481124 | Background | Park JH, Kim E, Seol EM, Kong SH, Park DJ, Yang HK, Choi JH, Park SH, Choe HN, Kweon M, Park J, Choi Y, Lee HJ. Prediction Model for Screening Patients at Risk of Malnutrition After Gastric Cancer Surgery. Ann Surg Oncol. 2021 Aug;28(8):4471-4481. doi: 10.1245/s10434-020-09559-3. Epub 2021 Jan 22. |
| 29503057 | Background | Oh SE, Choi MG, Seo JM, An JY, Lee JH, Sohn TS, Bae JM, Kim S. Prognostic significance of perioperative nutritional parameters in patients with gastric cancer. Clin Nutr. 2019 Apr;38(2):870-876. doi: 10.1016/j.clnu.2018.02.015. Epub 2018 Feb 20. |
| 34533290 | Background | Lee JK, Park YS, Lee K, Youn SI, Won Y, Min SH, Ahn SH, Park DJ, Kim HH. Prognostic significance of surgery-induced sarcopenia in the survival of gastric cancer patients: a sex-specific analysis. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1897-1907. doi: 10.1002/jcsm.12793. Epub 2021 Sep 17. |
| 33946039 | Background | Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15. |
| 33835329 | Background | Miyazaki Y, Omori T, Fujitani K, Fujita J, Kawabata R, Imamura H, Okada K, Moon JH, Hirao M, Matsuyama J, Saito T, Takahashi T, Kurokawa Y, Yamasaki M, Takiguchi S, Mori M, Doki Y; Osaka University Clinical Research Group for Gastroenterological Study. Oral nutritional supplements versus a regular diet alone for body weight loss after gastrectomy: a phase 3, multicenter, open-label randomized controlled trial. Gastric Cancer. 2021 Sep;24(5):1150-1159. doi: 10.1007/s10120-021-01188-3. Epub 2021 Apr 9. |
| 32563598 | Background | Meng Q, Tan S, Jiang Y, Han J, Xi Q, Zhuang Q, Wu G. Post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial. Clin Nutr. 2021 Jan;40(1):40-46. doi: 10.1016/j.clnu.2020.04.043. Epub 2020 Jun 2. |
| 33291698 | Background | Huang YH, Chiu WC, Hsu YP, Lo YL, Wang YH. Effects of Omega-3 Fatty Acids on Muscle Mass, Muscle Strength and Muscle Performance among the Elderly: A Meta-Analysis. Nutrients. 2020 Dec 4;12(12):3739. doi: 10.3390/nu12123739. |
| 33508285 | Background | Ortega L, Lobos-Gonzalez L, Reyna-Jeldes M, Cerda D, De la Fuente-Ortega E, Castro P, Bernal G, Coddou C. The Omega-3 fatty acid docosahexaenoic acid selectively induces apoptosis in tumor-derived cells and suppress tumor growth in gastric cancer. Eur J Pharmacol. 2021 Apr 5;896:173910. doi: 10.1016/j.ejphar.2021.173910. Epub 2021 Jan 26. |
| 33417481 | Background | Lu Z, Fang Y, Liu C, Zhang X, Xin X, He Y, Cao Y, Jiao X, Sun T, Pang Y, Wang Y, Zhou J, Qi C, Gong J, Wang X, Li J, Tang L, Shen L. Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial. J Clin Oncol. 2021 Mar 1;39(7):748-756. doi: 10.1200/JCO.20.01254. Epub 2021 Jan 8. |
| 37041057 | Derived | Zhou D, Liu Y, Zhang L, Lu M, Gao X, Li G, Xiang X, Xu H, Li G, Sun Z, Wei W, Yi K, Zuo J, Wu Y, Qian J, Zhou J, Duan K, Wu Y, Tian Z, Jiang C, Wang X. 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. 2023 Apr 11;13(4):e067990. doi: 10.1136/bmjopen-2022-067990. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |