Clinical trial · Interventional
Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer
The Effects of Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer on Long-term Disease-free Survival After Total Gastrectomy in Patients With Stage III Gastric Cancer
NCT05253716CI-TRIAL-00060588CRUCIALunknownN/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 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.
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 |
|---|---|---|---|
| Stage III 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
- immune nutrition support
- description
- 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.
- 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
- 3-year disease free survival after discharge
- timeFrame
- up to 3 years
- description
- from date of randomization to disease recurrence or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 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 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III 3. nutrition Risk Screening (NRS) 2002≥3 at discharge 4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge Exclusion Criteria: 1. unable to oral or consume ONS 2. has received neoadjuvant chemotherapy 3. pregnancy 4. palliative surgery or gastric stump cancer or Borrmann type IV 5. oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease 6. serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension 7. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia 8. diabetes has developed complications or uncontrolled by medications 9. previous use of drugs affecting immune function 10. previous use of fish oil capsule \> 2 times / week or contraindications to fish oil capsule 11. motor system diseases cannot complete grip strength measurement and 5-time chair stand test
References
Publications (14)
- BACKGROUNDHeneghan 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. PMID 26583669
- BACKGROUNDHuang 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. PMID 32913478
- BACKGROUNDZheng 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. PMID 28699132
- BACKGROUNDOngaro 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. PMID 28477106
- BACKGROUNDPark 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. PMID 33481124
- BACKGROUNDOh 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.