The present clinical trial was designed to explore the effect of postoperative physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer.
The present clinical trial was designed to explore the effect of physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer. In the trial group, comprehensive postoperative management model with targeted exercise intervention and nutritional support. The details are as follows: 1. Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of enteral nutrition supplement (ONS) in addition to their normal diet. Once the patient's oral diet decreases, ONS will be added several times a day to ensure that the total energy reaches the ESPEN recommended daily 30 kcal/kg. The daily protein requirement is set at 1.2-1.5 g/kg of actual body weight. The Dietitian will keep records and help patients adjust their energy intake weekly. 2. Exercise: under the guidance of the rehabilitation therapist, the patient gradually recovers Exercise from discharge (7-14 days after the operation) to 6 months after the operation, and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week; The control group patients received the same baseline evaluation as the experimental group patients. The control group will not receive phisical exercise intervention, but will receive postoperative nutritional treatment with the same standards as the experimental group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
960
1. Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of oral nutrition supplement (ONS) in addition to their normal diet.. 2. Exercise: under the guidance of the rehabilitation therapist, the patient gradually recovers Exercise from discharge (7-14 days after the operation) to 6 months after the operation, and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week;
(1) Nutrition intervention: From discharge (7-14 days after surgery) until 6 months after surgery, patients are required to take 400 kcal/day of oral nutrition supplement (ONS) in addition to their normal diet..
3-year overall survival rate
The 3-year overall survival rate refers to the proportion of gastric cancer patients who have survived for more than 3 years after various comprehensive treatments
Time frame: 3 years after surgery
3-year disease-free survival rate
The proportion of clinically confirmed complete remission to recurrence within 3 years
Time frame: 3 years after surgery
Scored Patient-Generated Subjective Global Assessment, PG-SGA
Scored Patient-Generated Subjective Global Assessment is the preferred method recommended by the American Dietitian Association for nutritional screening of tumor patients. It can conduct qualitative and quantitative comprehensive evaluation of patients' nutritional status from four aspects: weight loss, disease and age, metabolic stress status, and physical examination. It is a sensitive evaluation scale for patients to malnutrition changes
Time frame: 6 months after surgery
QLQ-C30 assessment
The quality of life of patients 6 months after surgery was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), which can evaluate the quality of life from a multidimensional perspective and better reflect the connotation of quality of life. It is widely used in clinical practice to measure the quality of life of cancer patients.
Time frame: 6 months after surgery
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