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

Qingdao University

Status: Active, not recruiting

Conditions: Frail Elderly; Stomach Neoplasms

Treatments: Behavioral: ERAS protocol; Behavioral: Multimodal prehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT05352802

GISSG+2201

Details and patient eligibility

About

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.

Enrollment: 368 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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368 participants in 2 patient groups

Prehabilitation group

Experimental group

Description:

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

Treatment:

Behavioral: Multimodal prehabilitation program

Behavioral: ERAS protocol

ERAS group

Active Comparator group

Description:

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

Treatment:

Behavioral: ERAS protocol