ONS in Gastric Cancer After Total Gastrectomy
Study Details
Study Description
Brief Summary
Gastric cancer patients after total gastrectomy will be randomized to oral nutritional supplement group or control group at discharge. Patients will receive 6 months of oral nutritional supplement or normal diet after discharge. The primary and secondary outcomes will be collected.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Gastric cancer patients after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to oral nutritional supplement (ONS) group or control (C) group after discharge. In the ONS group, in addition to diet, and patients will also consume enteral nutritional powder (500ml/d，500kcal/d) 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: oral nutritional supplement In the oral nutritional supplement group, in addition to diet, and patients will also consume enteral nutrition powder (500 ml/d, 500kcal/d) lasted for 6 months after discharge. |
Other: ONS
oral nutritional supplement
|
| No Intervention: control In the control group, patients will receive nutrition counseling in addition to diet. |
Outcome Measures
Primary Outcome Measures
- incidence of sarcopenia 6-month after discharge [up to 6 months.]
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
Secondary Outcome Measures
- incidence of sarcopenia 1 year after discharge [up to 12 months.]
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
- unplanned readmission rate [up to 6 months.]
readmission due to unplanned reason
- toxicity of chemotherapy graded according to the CTCAE, version 5.0 [up to 6 months.]
Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0.
- Quality of life after discharge [up to 12 months.]
Quality of life assessed by EORTC QLQ-C30
- Changes in BMI (weight and height will be combined to report BMI in kg/m^2) [up to 12 months.]
nutritional status after discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Informed consent of patients or their legal representatives to participate in this study
-
consecutive adult (18-80 years) patients underwent radical gastrectomy (total gastrectomy)
-
nutrition Risk Screening (NRS) 2002≥3 at discharge
-
eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
-
normal liver and kidney function
Exclusion Criteria:
-
unable to oral or consume ONS
-
allergy to any ingredient in the oral nutrition powder
-
pregnancy
-
palliative surgery or gastric stump cancer
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congenital acquired immune deficiency disease
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severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications
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motor system diseases cannot complete grip strength measurement and 5-time chair stand test
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have cognitive impairment, unable to complete the relevant questionnaires
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expected to require tube feeding after discharge from the hospital
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jinling Hospital, China | Nanjing | Jiangsu | China | 210002 |
Sponsors and Collaborators
- Jinling Hospital, China
- Zhongda Hospital
- Shandong Provincial Hospital
- Hebei Medical University Fourth Hospital
- Zunyi Medical College
- Xinqiao Hospital of Chongqing
Investigators
- Principal Investigator: Xinying Wang, MD, Jinling Hosptial
Study Documents (Full-Text)
None provided.More Information
Publications
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- Kudou K, Saeki H, Nakashima Y, Sasaki S, Jogo T, Hirose K, Hu Q, Tsuda Y, Kimura K, Nakanishi R, Kubo N, Ando K, Oki E, Ikeda T, Maehara Y. Postoperative development of sarcopenia is a strong predictor of a poor prognosis in patients with adenocarcinoma of the esophagogastric junction and upper gastric cancer. Am J Surg. 2019 Apr;217(4):757-763. doi: 10.1016/j.amjsurg.2018.07.003. Epub 2018 Jul 10.
- 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.
- Li Q, Zhang X, Tang M, Song M, Zhang Q, Zhang K, Ruan G, Zhang X, Ge Y, Yang M, Liu Y, Xu H, Song C, Wang Z, Shi H. Different muscle mass indices of the Global Leadership Initiative on Malnutrition in diagnosing malnutrition and predicting survival of patients with gastric cancer. Nutrition. 2021 Sep;89:111286. doi: 10.1016/j.nut.2021.111286. Epub 2021 Apr 24.
- 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.
- 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.
- Takahashi S, Shimizu S, Nagai S, Watanabe H, Nishitani Y, Kurisu Y. Characteristics of sarcopenia after distal gastrectomy in elderly patients. PLoS One. 2019 Sep 11;14(9):e0222412. doi: 10.1371/journal.pone.0222412. eCollection 2019.
- Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.
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