Multimodal Prehabilitation for Resectable Gastric Cancer

Not Applicable

Completed

• Conditions: Stomach Neoplasm
• Interventions: Behavioral: aerobic exercise; resistance exercise; nutritional support; psychological support

• Registration Number: NCT05714878
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Surgical resection is the mainstay for gastric cancer. Surgical stress response, like insulin resistance and catabolism, is inevitable and is a risk factor for postoperative outcome. To cope with this stress, the enhanced recovery protocol has been proposed and successfully implemented in clinical practice. Recently, prehabilitation have attracted increasingly attention, which is the preoperative part of enhanced recovery pathway. Prehabtilitation are bundles of evidenced elements in order to improve patient's functional capacity. Patients with gastric cancer are usually suffered from nutritional risk, anxiety and frailty. In this trial, we investigate whether multimodal prehabilitation (exercise, nutrition and psychological support) could improve patient's functional status to better tolerate surgical trauma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-06
• Study Start: 2023-03-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Pathologically confirmed gastric cancer, clinical I-III TNM stage (AJCC 8th edition);
• Will receive curative-intent surgery;
• Life expectance > 6 months;

Exclusion Criteria

• Gastric stump cancer or combined with other malignances;
• NYHA III, NYHA IV;
• Inability to swallow, with gastrostomy, or inability to move because of orthopedic disease or neuromuscular disease;
• Psychiatric disorders, COPD, end-stage hepatic or renal disease, uncontrolled cardiac arhythmia or uncontrolled hypertention;
• Receiving immunosuppressive therapy;
• Emergency surgery because of tumor bleeding or tumor perforation;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation arm	aerobic exercise; resistance exercise; nutritional support; psychological support	Patient receives prehabilitation intervention including exercise, nutrition and psychological support.

Primary Outcome Measures

Name	Time	Method
Duke Activity Status Index before surgery	Duke Activity Status Index score on the day before surgery	Duke Activity Status Index score is a 12-item self-reported questionnaire that assesses daily activities such as personal care, ambulation, household tasks, and recreation with respective metabolic costs. Duke Activity Status Index score ranges from 0 to 58.2. The higher score indicates the better functional status. Duke Activity Status Index has been recommended by European Society of Cardiology guidelines for functional assessment of patients undergoing non-cardiac surgery.

Secondary Outcome Measures

Name	Time	Method
Postoperative hospital stay	During the postoperative 30 day period	Period from day of surgery to day of discharge from hospital
30-day readmission rate	During the postoperative 30 day period	Proportion of patients admitted to the hospital after discharge because of complications
Morbidity	In postoperative 30 day after gastrectomy	Postoperative complication

Trial Locations

Locations (1)

Chinese PLA General Hospital First Medical Center; 🇨🇳 Beijing, China