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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
696
Immunonutritional supplement
Jinling Hospital, China
Nanjing, Jiangsu, China
RECRUITING3-year disease free survival after discharge
from date of randomization to disease recurrence or death
Time frame: up to 3 years
3-year overall survival
from date of randomization to death due to any reason,
Time frame: up to 3 years.
unplanned readmission rate
readmission due to unplanned reason
Time frame: up to 6 months.
Quality of life after discharge
Quality of life assessed by EORTC QLQ-C30
Time frame: up to 12 months.
incidence of sarcopenia after discharge
sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.
Time frame: up to 12 months.
Changes in BMI (weight and height will be combined to report BMI in kg/m^2)
nutritional status after discharge
Time frame: up to 12 months.
Changes in albumin level
nutritional status after discharge
Time frame: up to 12 months.
Changes in prealbumin level
nutritional status after discharge
Time frame: up to 12 months.
Changes in hemoglobin level
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nutritional status after discharge
Time frame: up to 12 months.
Changes in weight
nutritional status after discharge
Time frame: up to 12 months.
toxicity of chemotherapy graded according to the CTCAE, version 5.0
Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0.
Time frame: up to 6 months.