Effect of Exercise and Enteral Nutrition on Survival

Trial Title: Effect of Exercise and Enteral Nutrition on Survival

NCT ID: NCT05959226

Condition: Gastric Cancer
Nutrition Related Cancer
Sarcopenia

Conditions: Official terms:
Stomach Neoplasms
Sarcopenia

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Exercise Intervention
Description: 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;
Arm group label: Exercise and Enteral Nutrition Intervention

Intervention type: Dietary Supplement
Intervention name: Nutrition Intervention
Description: (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..
Arm group label: Enteral Nutrition Intervention
Arm group label: Exercise and Enteral Nutrition Intervention

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria:（1) 18 years ≤ age ≤ 70 years (2) Preoperative Karnofsky physical condition score: 0 or 1 or 2 (3) Preoperative pathological biopsy by gastroscope, histologically confirmed as adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma, mixed adenocarcinoma) (4) Gastric cancer patients diagnosed with clinical stage Ib IIIc through CT, MRI, gastroscopy, and pathology (based on the 8th edition of UICC/AJCC staging) (5) Abdominal enhanced CT/MRI examination showed a clinical staging of cT2-4aN0-3M0 (based on AJCC-8thTNM tumor staging), and standard D2 radical surgery for gastric cancer was performed; (6) Have not received any radiotherapy, chemotherapy or immunotherapy; (7) Hemoglobin ≥ 80g/L; (8) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; (9) Platelets ≥ 75 × 109/L; (10) ALT ≤ 2.5 times the normal upper limit value; (11) AST ≤ 2.5 times the normal upper limit value; (12) ALP ≤ 2.5 times the normal upper limit value; (13) Serum total bilirubin<1.5 times the upper normal limit value; (14) Serum creatinine<1 times the upper normal limit value; (15) Sign written informed consent; Exclusion Criteria: 1. Patients diagnosed with distant metastasis through abdominal lung CT/MRI or PET-CT 2. Pregnant or lactating women 3. People with uncontrolled epilepsy, Central nervous system disease or mental disorders 4. Patients with combined limb disabilities or motor dysfunction; 5. Patients with other malignant diseases in the past five years, excluding cured skin cancer and cervical Carcinoma in situ 6. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction within the past 6 months 7. Have a history of cerebral infarction or cerebral hemorrhage in the past 6 months 8. Organ transplantation requires immunosuppressive therapy 9. Serious uncontrolled recurrent infections or other serious uncontrolled concomitant diseases 10. The patient has complications of Grade III or above in Clavien Dindo classification or has been hospitalized for more than 14 days after surgery due to various reasons; 11. Urgent surgery required due to tumor emergencies (bleeding, perforation, obstruction) 12. Pulmonary function test FEV1

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Start date: August 1, 2023

Completion date: August 1, 2028

Lead sponsor:
Agency: The First Hospital of Jilin University
Agency class: Other

Source: The First Hospital of Jilin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05959226