ONS in Gastric Cancer After Total Gastrectomy

Study Overview
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Brief Summary
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Gastric cancer patients after total gastrectomy will be randomized to oral nutritional supplement group or control group at discharge. Patients will receive 6 months of oral nutritional supplement or normal diet after discharge. The primary and secondary outcomes will be collected.

Detailed Description
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Gastric cancer patients after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to oral nutritional supplement (ONS) group or control (C) group after discharge. In the ONS group, in addition to diet, and patients will also consume enteral nutritional powder (500ml/d，500kcal/d) 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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Effect of Oral Nutritional Supplement on Nutritional Status and Clinical Outcome in Gastric Cancer Patients After Total Gastrectomy

Conditions
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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 (18-80 years) patients underwent radical gastrectomy (total gastrectomy) nutrition Risk Screening (NRS) 2002≥3 at discharge eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge normal liver and kidney function Exclusion Criteria: unable to oral or consume ONS allergy to any ingredient in the oral nutrition powder pregnancy palliative surgery or gastric stump cancer congenital acquired immune deficiency disease severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications motor system diseases cannot complete grip strength measurement and 5-time chair stand test have cognitive impairment, unable to complete the relevant questionnaires expected to require tube feeding after discharge from the hospital

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: oral nutritional supplement<br>In the oral nutritional supplement group, in addition to diet, and patients will also consume enteral nutrition powder (500 ml/d, 500kcal/d) lasted for 6 months after discharge. | Other: ONS<br>* oral nutritional supplement<br>|
| 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 |
| --- | --- | --- |
| incidence of sarcopenia 6-month after discharge | sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability. | up to 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of sarcopenia 1 year after discharge | sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability. | up to 12 months. | 
| unplanned readmission rate | readmission due to unplanned reason | up to 6 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. | 
| Quality of life after discharge | Quality of life assessed by EORTC QLQ-C30 | 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. | 

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