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Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer

Recruiting
18 years of age
Both
Phase N/A

Overview

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.

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) group after discharge. In the INS 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 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.

Eligibility

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

Study details

Stage III Gastric Cancer

NCT05253716

Jinling Hospital, China

28 January 2024

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