RecruitingNot ApplicableNCT05253716
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
Sponsor
Jinling Hospital, China
Enrollment
696 participants
Start Date
Aug 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Informed consent of patients or their legal representatives to participate in this study
- consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
- nutrition Risk Screening (NRS) 2002≥3 at discharge
- eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
Exclusion Criteria11
- unable to oral or consume ONS
- has received neoadjuvant chemotherapy
- pregnancy
- palliative surgery or gastric stump cancer or Borrmann type IV
- oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease
- serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension
- severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia
- diabetes has developed complications or uncontrolled by medications
- previous use of drugs affecting immune function
- previous use of fish oil capsule \> 2 times / week or contraindications to fish oil capsule
- motor system diseases cannot complete grip strength measurement and 5-time chair stand test
Interventions
OTHERONS
Immunonutritional supplement
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05253716