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Clinical Trials in China / NCT05352802
Active, not recruiting Not applicable

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

NCT05352802 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Hospital of Qingdao University
Phase
Not applicable
Started
2022-09-01
Last updated
2024-12-13

Condition(s) studied

Stomach NeoplasmsFrail Elderly

Investigational drug(s) / intervention(s)

Multimodal prehabilitation programERAS protocol

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.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital Qingdao Shandong

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Other trials for the same condition

Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy Recruiting
Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer Starting soon
Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer Recruiting
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05352802 on ClinicalTrials.gov ↗ ← All trials in China