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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05352802
• Other study ID #: GISSG+2201
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: Yanbing Zhou, MD
• Phone: 86532-82911324
• Email: zhouyanbing[@]qduhospital.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital	Qingdao	Shandong

Sponsors (13)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University	Dongying People's Hospital, Liaocheng People's Hospital, Qianfoshan Hospital, Qilu Hospital of Shandong University, Rizhao People's Hospital, Shandong Jining No.1 People's Hospital, Shandong Provincial Hospital, Weifang Medical University, Weifang People's Hospital, Weihai Central Hospital, Weihai Municipal Hospital, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Oncological outcomes	3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.	3 years