Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer

Study Overview
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Brief Summary
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The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.

Official Title
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Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer: A Multicenter Randomized Controlled Trial

Conditions
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Stomach Neoplasms, Frail Elderly

Intervention / Treatment
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* Behavioral: Multimodal prehabilitation program
* Behavioral: ERAS protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 65-85 years; Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; G8 score ≤14; Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma; Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection; Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic); Date of surgery ≥2 weeks from baseline (T0) assessment; Physical conditions could meet the requirements of exercise training, and no severe concomitant disease; All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time. Exclusion Criteria: Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders; End-stage cardiac insufficiency (LVEF<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV; Cerebral bleeding or infarction (within 6 months); Patients with recurrent infection diseases or serious concomitant disease; Patients who require synchronous surgery due to other illness; Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation); Patients who are participating in any other clinical trials.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation group<br>The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy. | Behavioral: Multimodal prehabilitation program<br>* Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.<br>Behavioral: ERAS protocol<br>* The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.<br>|
| Active Comparator: ERAS group<br>The ERAS group patients were treated according to the ERAS pathway. | Behavioral: ERAS protocol<br>* The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of postoperative complications | Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score. | Postoperative (≤30 days after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio-pulmonary function and physical capacity | The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function. | Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery） | 
| Quality of life (QoL). | QoL comprises patient-reported outcomes (PRO) of physical symptoms and psychosocial health status. Quality of Life Questionnaire (QLQ) C30 is sensitive tool for measuring individual performance status. Each index score ranges from 1 to 4, with higher scores indicating higher risk. | Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery） | 
| Detection of immune and inflammatory indicators | Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations | Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery） | 
| The postoperative other observation parameters | Postoperative pain severity, postoperative delirium severity and occurrence, first exhaust and defecation, ureteral catheter removal, abdominal drainage tubes removal, postoperative hospital stay, hospitalization costs, 30-day all-cause mortality and 30-day hospital readmission rate. | Postoperative (≤30 days after surgery) | 
| Oncological outcomes | 3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multimodal prehabilitation, ERAS