Clinical trial · Interventional
ONS in Gastric Cancer After Total Gastrectomy
Effect of Oral Nutritional Supplement on Nutritional Status and Clinical Outcome in Gastric Cancer Patients After Total Gastrectomy
NCT05823272CI-TRIAL-00075312unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONS | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- oral nutritional supplement
- description
- 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.
- interventionNames
- Other: ONS
- type
- NO_INTERVENTION
- label
- control
- description
- In the control group, patients will receive nutrition counseling in addition to diet.
Primary outcomes (1)
- measure
- incidence of sarcopenia 6-month after discharge
- timeFrame
- up to 6 months.
- description
- sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Informed consent of patients or their legal representatives to participate in this study 2. consecutive adult (18-80 years) patients underwent radical gastrectomy (total gastrectomy) 3. nutrition Risk Screening (NRS) 2002≥3 at discharge 4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge 5. normal liver and kidney function Exclusion Criteria: 1. unable to oral or consume ONS 2. allergy to any ingredient in the oral nutrition powder 3. pregnancy 4. palliative surgery or gastric stump cancer 5. congenital acquired immune deficiency disease 6. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications 7. motor system diseases cannot complete grip strength measurement and 5-time chair stand test 8. have cognitive impairment, unable to complete the relevant questionnaires 9. expected to require tube feeding after discharge from the hospital
References
Publications (12)
- BACKGROUNDYu 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. PMID 31135850
- BACKGROUNDDeng ZJ, Nie RC, Lu J, Chen XJ, Xiang J, Huang CM, Chen YB, Peng JS, Chen S. Survival analysis of stage II gastric cancer patients after D2 gastrectomy: a Chinese people-based research. BMC Gastroenterol. 2021 Oct 7;21(1):363. doi: 10.1186/s12876-021-01937-9. PMID 34620108
- BACKGROUNDLi 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. PMID 34090215
- BACKGROUNDDavis JL, Selby LV, Chou JF, Schattner M, Ilson DH, Capanu M, Brennan MF, Coit DG, Strong VE. Patterns and Predictors of Weight Loss After Gastrectomy for Cancer. Ann Surg Oncol. 2016 May;23(5):1639-45. doi: 10.1245/s10434-015-5065-3. Epub 2016 Jan 5. PMID 26732274
- BACKGROUNDTakahashi 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. PMID 31509590
- BACKGROUNDFearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.