Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer
- Conditions
- Stage III Gastric Cancer
- Interventions
- Other: ONS
- Registration Number
- NCT05253716
- Lead Sponsor
- Jinling Hospital, China
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 696
- Informed consent of patients or their legal representatives to participate in this study
- consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
- nutrition Risk Screening (NRS) 2002≥3 at discharge
- eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
- unable to oral or consume ONS
- has received neoadjuvant chemotherapy
- pregnancy
- palliative surgery or gastric stump cancer or Borrmann type IV
- oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease
- serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension
- severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia
- diabetes has developed complications or uncontrolled by medications
- previous use of drugs affecting immune function
- previous use of fish oil capsule > 2 times / week or contraindications to fish oil capsule
- motor system diseases cannot complete grip strength measurement and 5-time chair stand test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description immune nutrition support ONS In the immune nutrition support 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 after discharge lasted for 6 months.
- Primary Outcome Measures
Name Time Method 3-year disease free survival after discharge up to 3 years from date of randomization to disease recurrence or death
- Secondary Outcome Measures
Name Time Method Changes in weight up to 12 months. nutritional status after discharge
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 prealbumin level up to 12 months. nutritional status after discharge
Changes in hemoglobin level 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.
Changes in albumin level up to 12 months. nutritional status after discharge
Trial Locations
- Locations (1)
Jinling Hospital, China
🇨🇳Nanjing, Jiangsu, China