Status:
RECRUITING
Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer
Lead Sponsor:
Jinling Hospital, China
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
The Affiliated cancer hospital of Nanjing Medical University
Conditions:
Stage III Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
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) g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
696 Patients enrolled
Trial Details
Trial ID
NCT05253716
Start Date
August 1 2022
End Date
March 1 2026
Last Update
August 29 2022
Active Locations (1)
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1
Jinling Hospital, China
Nanjing, Jiangsu, China, 210002