ONS in Gastric Cancer After Total Gastrectomy

Jinling Hospital, China

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Other: ONS

Study type: Interventional

Funder types: Other

Identifiers

NCT05823272

2022-7-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

oral nutritional supplement

Experimental group

Description:

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.

Treatment:

Other: ONS

control

No Intervention group

Description:

In the control group, patients will receive nutrition counseling in addition to diet.