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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stomach Neoplasms; Frail Elderly
• Intervention / Treatment: Behavioral: Multimodal prehabilitation program; Behavioral: ERAS protocol

• Study Type: Interventional
• Enrollment (Anticipated): 368
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanbing Zhou, MD; Phone Number: 86532-82911324; Email: zhouyanbing@qduhospital.cn
• Study Contact Backup: Name: Yuqi Sun, MD; Phone Number: 86532-82911324; Email: 2021010097@qdu.edu.cn

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
      • Contact: Yanbing Zhou, MD; Phone Number: 86532-82911324; Email: zhouyanbing@qduhospital.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation group; The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.	Behavioral: Multimodal prehabilitation program; Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.; Behavioral: ERAS protocol; 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.
Active Comparator: ERAS group; The ERAS group patients were treated according to the ERAS pathway.	Behavioral: ERAS protocol; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Collaborators: Qilu Hospital of Shandong University; Shandong Provincial Hospital; Qianfoshan Hospital; Yantai Yuhuangding Hospital; Shandong Jining No.1 People's Hospital; Liaocheng People's Hospital; Weihai Municipal Hospital; Weifang People's Hospital; Weifang Medical University; Weihai Central Hospital; Dongying People's Hospital; Rizhao People's Hospital
• Investigators: Study Director: Yanbing Zhou, MD, The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 24, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ERAS; Multimodal prehabilitation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: GISSG+2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No