ONS in Gastric Cancer After Total Gastrectomy

Not Applicable

Recruiting

• Conditions: Gastric Cancer
• Interventions: Other: ONS

• Registration Number: NCT05823272
• Lead Sponsor: Jinling Hospital, China

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Study Start: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-08-05
• Study Completion: 2024-08-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 hospital

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral nutritional supplement	ONS	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.

Primary Outcome Measures

Name	Time	Method
incidence of sarcopenia 6-month after discharge	up to 6 months.	sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.

Secondary Outcome Measures

Name	Time	Method
incidence of sarcopenia 1 year after discharge	up to 12 months.	sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
unplanned readmission rate	up to 6 months.	readmission due to unplanned reason
Quality of life after discharge	up to 12 months.	Quality of life assessed by EORTC QLQ-C30
toxicity of chemotherapy graded according to the CTCAE, version 5.0	up to 6 months.	Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0.
Changes in BMI (weight and height will be combined to report BMI in kg/m^2)	up to 12 months.	nutritional status after discharge

Trial Locations

Locations (1)

Jinling Hospital, China; 🇨🇳 Nanjing, Jiangsu, China