Effect of Exercise and Enteral Nutrition on Survival
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Hospital of Jilin University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients diagnosed with distant metastasis through abdominal lung CT/MRI or PET-CT
Pregnant or lactating women
People with uncontrolled epilepsy, Central nervous system disease or mental disorders
Patients with combined limb disabilities or motor dysfunction;
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Intervention
Behavioral1. 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;
Nutrition Intervention
Dietary supplement(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..
Treatment groups
960 Participants
are divided into 2 treatment groupsGroup A: Exercise and Enteral Nutrition InterventionExperimental treatment 2 interventions
Group B: Enteral Nutrition InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
3-year disease-free survival rate
The proportion of clinically confirmed complete remission to recurrence within 3 years
Time frame
3 years after surgery2
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 surgery3
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 surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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