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ONS in Gastric Cancer After Total Gastrectomy
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
1. Informed consent of patients or their legal representatives to participate in this study. 2. consecutive adult (18-80 years) patients underwent radical gastrectomy (total gastrectomy) 3. nutrition Risk Screening (NRS) 2002≥3 at discharge. 4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge. 5. normal liver and kidney function.Exclusion Criteria:
1. unable to oral or consume ONS. 2. allergy to any ingredient in the oral nutrition powder. 3. pregnancy. 4. palliative surgery or gastric stump cancer. 5. congenital acquired immune deficiency disease. 6. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications. 7. motor system diseases cannot complete grip strength measurement and 5-time chair stand test. 8. have cognitive impairment, unable to complete the relevant questionnaires. 9. expected to require tube feeding after discharge from the hospitalTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The person who is responsible for the scientific and technical direction of the entire clinical study.
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The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
Experimental: oral nutritional supplement
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.
No Intervention: control
In the control group, patients will receive nutrition counseling in addition to diet.
Interventions
Other: - ONS
oral nutritional supplement
Contact a Trial Team
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International Sites
Status
Recruiting
Address
Jinling Hospital, China
Nanjing, Jiangsu, 210002
Site Contact
Xinying Wang, MD
[email protected]
+86 13913028866
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