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

Not Applicable

Active, not recruiting

• Conditions: Stomach Neoplasms; Frail Elderly
• Interventions: Behavioral: ERAS protocol; Behavioral: Multimodal prehabilitation program

• Registration Number: NCT05352802
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-24
• Study First Posted: 2022-04-29
• Study Start: 2022-09-01
• Primary Completion: 2024-04-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

1. Aged 65-85 years;
2. Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
3. G8 score ≤14;
4. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
5. Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
6. Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
7. Date of surgery ≥2 weeks from baseline (T0) assessment;
8. Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
9. 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.

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Exclusion Criteria

1. Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
2. 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;
3. Cerebral bleeding or infarction (within 6 months);
4. Patients with recurrent infection diseases or serious concomitant disease;
5. Patients who require synchronous surgery due to other illness;
6. Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
7. Patients who are participating in any other clinical trials.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	ERAS protocol	The ERAS group patients were treated according to the ERAS pathway.
Prehabilitation group	Multimodal prehabilitation program	The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.
Prehabilitation group	ERAS protocol	The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.

Primary Outcome Measures

Name	Time	Method
The incidence and severity of postoperative complications	Postoperative (≤30 days after surgery)	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.

Secondary Outcome Measures

Name	Time	Method
Oncological outcomes	3 years	3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.
Cardio-pulmonary function and physical capacity	Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）	The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function.
Quality of life (QoL).	Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）	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.
Detection of immune and inflammatory indicators	Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）	Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations
The postoperative other observation parameters	Postoperative (≤30 days after surgery)	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.

Trial Locations

Locations (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital; 🇨🇳 Qingdao, Shandong, China