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

  • STATUS
    Recruiting
  • End date
    Mar 19, 2026
  • participants needed
    696
  • sponsor
    Jinling Hospital, China
Updated on 7 October 2022

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.

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.

Details
Condition Stage III Gastric Cancer
Treatment ONS
Clinical Study IdentifierNCT05253716
SponsorJinling Hospital, China
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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