Gastric Cancer
Conditions
Keywords
Oral nutritional supplement, Sarcopenia, long-term nutritional status
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.
Interventions
OTHERONS
oral nutritional supplement
Sponsors
Zhongda Hospital
Shandong Provincial Hospital
Hebei Medical University Fourth Hospital
Zunyi Medical College
Xinqiao Hospital of Chongqing
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Quality of life after discharge | up to 12 months. | Quality of life assessed by EORTC QLQ-C30 |
| Changes in BMI (weight and height will be combined to report BMI in kg/m^2) | up to 12 months. | nutritional status after discharge |
Countries
China
Contacts
Primary ContactTingting Gao, MS
Outcome results
None listed