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

NCT05352802 | Active Not Recruiting DMC

• 1 other identifier: GISSG+2201
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms; Frail Elderly

Keywords

Multimodal prehabilitation; ERAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cardio-pulmonary function and physical capacity

  Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）

• Quality of life (QoL).

  Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）

• Detection of immune and inflammatory indicators

  Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）

• The postoperative other observation parameters

  Postoperative (≤30 days after surgery)

• Oncological outcomes

  3 years

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.

Behavioral: Multimodal prehabilitation program; Behavioral: ERAS protocol

ERAS group

ACTIVE COMPARATOR

The ERAS group patients were treated according to the ERAS pathway.

Behavioral: ERAS protocol

Interventions

Multimodal prehabilitation program BEHAVIORAL

Multimodal prehabilitation programs have adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.

Prehabilitation group

ERAS protocol BEHAVIORAL

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.

ERAS group; Prehabilitation group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Shandong Provincial Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Qianfoshan Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Jining First People's Hospital: collaborator
• Weifang Medical University: collaborator
• Weifang People's Hospital: collaborator
• Dongying People's Hospital: collaborator
• Weihai Municipal Hospital: collaborator
• Weihai Central Hospital: collaborator
• Rizhao People's Hospital: collaborator
• Liaocheng People's Hospital: collaborator

Study Sites (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

Location

Related Publications (2)

• Sun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Liu Q, Zhou Y. Supervised Multimodal Prehabilitation and Clinical Outcomes in Older Patients With Frailty and Gastric Cancer: The GISSG+2201 Randomized Clinical Trial. JAMA Surg. 2026 Jan 28. doi: 10.1001/jamasurg.2025.6256. Online ahead of print.

  PMID: 41604182 DERIVED

• Sun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Meng C, Kehlet H, Zhou Y. Multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer: a study protocol for a multicentre randomised controlled trial (GISSG+2201). BMJ Open. 2023 Oct 10;13(10):e071714. doi: 10.1136/bmjopen-2023-071714.

  PMID: 37816552 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yanbing Zhou, MD

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 29, 2022
• Study Start: September 1, 2022
• Primary Completion: April 13, 2024
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)