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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Stage III Gastric Cancer

Intervention / Treatment
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* Other: ONS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immune nutrition support<br>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. | Other: ONS<br>* Immunonutritional supplement<br>* Other names: fish oil;|
| No Intervention: control<br>In the control group, patients will receive nutrition counseling in addition to diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival after discharge | from date of randomization to disease recurrence or death | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival | from date of randomization to death due to any reason, | up to 3 years. | 
| unplanned readmission rate | readmission due to unplanned reason | up to 6 months. | 
| Quality of life after discharge | Quality of life assessed by EORTC QLQ-C30 | up to 12 months. | 
| incidence of sarcopenia after discharge | sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability. | up to 12 months. | 
| Changes in BMI (weight and height will be combined to report BMI in kg/m^2) | nutritional status after discharge | up to 12 months. | 
| Changes in albumin level | nutritional status after discharge | up to 12 months. | 
| Changes in prealbumin level | nutritional status after discharge | up to 12 months. | 
| Changes in hemoglobin level | nutritional status after discharge | up to 12 months. | 
| Changes in weight | nutritional status after discharge | up to 12 months. | 
| toxicity of chemotherapy graded according to the CTCAE, version 5.0 | Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0. | up to 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutritional supplement, Immunonutrition, long-term survival