Effect of Exercise and Enteral Nutrition on Survival

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2028-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Cancer Nutrition Related Cancer Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise and Enteral Nutrition Intervention

A comprehensive postoperative management combined physical exercise intervention with oral nutritional support

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

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;

Nutrition Intervention

Intervention Type 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..

Enteral Nutrition Intervention

The control group will not receive exercise intervention, but will receive postoperative nutritional support treatment with the same standards as the experimental group.

Group Type ACTIVE_COMPARATOR

Nutrition Intervention

Intervention Type 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..

Interventions

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Exercise Intervention

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;

Intervention Type BEHAVIORAL

Nutrition Intervention

(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..

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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\<expected value 50%
13. Received radiotherapy, chemotherapy, or other neoadjuvant treatment before surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No