Stage III Gastric Cancer
Conditions
Keywords
Oral nutritional supplement, Immunonutrition, long-term survival
Brief summary
Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected.
Detailed description
Gastric cancer patients with stage III after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to immune nutrition support (INS) or control (C) group after discharge. In the INS group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil 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
Immunonutritional supplement
Sponsors
The First Affiliated Hospital with Nanjing Medical University
The Affiliated cancer hospital of Nanjing Medical University
Nanjing Jiangning Hospital
Zhenjiang First People's Hospital
The Third Affiliated Hospital of Soochow University
ChangZhou Second hospital
The First Affiliated Hospital of Soochow University
Second Affiliated Hospital of Soochow University
Yixing People's Hospital
The Second Hospital of Nanjing Medical University
Wuxi People's Hospital
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent of patients or their legal representatives to participate in this study 2. consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III 3. nutrition Risk Screening (NRS) 2002≥3 at discharge 4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
Exclusion criteria
1. unable to oral or consume ONS 2. has received neoadjuvant chemotherapy 3. pregnancy 4. palliative surgery or gastric stump cancer or Borrmann type IV 5. oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease 6. serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension 7. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia 8. diabetes has developed complications or uncontrolled by medications 9. previous use of drugs affecting immune function 10. previous use of fish oil capsule \> 2 times / week or contraindications to fish oil capsule 11. motor system diseases cannot complete grip strength measurement and 5-time chair stand test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival after discharge | up to 3 years | from date of randomization to disease recurrence or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival | up to 3 years. | from date of randomization to death due to any reason, |
| 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 |
| incidence of sarcopenia after discharge | up to 12 months. | sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability. |
| Changes in BMI (weight and height will be combined to report BMI in kg/m^2) | up to 12 months. | nutritional status after discharge |
| Changes in albumin level | up to 12 months. | nutritional status after discharge |
| Changes in prealbumin level | up to 12 months. | nutritional status after discharge |
| Changes in hemoglobin level | up to 12 months. | nutritional status after discharge |
| Changes in weight | up to 12 months. | nutritional status after discharge |
| 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. |
Countries
China
Contacts
Primary ContactTingting Gao, MS
Outcome results
None listed