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NCT Number: NCT05352802

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Multimodal prehabilitation Program

Behavioral

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

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.

Primary outcomes

  1. The incidence and severity of postoperative complications

    Time frame: 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.

Secondary outcomes

  1. Cardio-pulmonary function and physical capacity

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

    The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardio-pulmonary function.

  2. Quality of life (QoL).

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

    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.

  3. Detection of immune and inflammatory indicators

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

    Interleukin, Tumor necrosis factor and C-reactive protein serum concentrations

  4. The postoperative other observation parameters

    Time frame: Postoperative (≤30 days after surgery)

    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.

  5. Oncological outcomes

    Time frame: 3 years

    3-year recurrence-free survival (RFS) rate and 3-year overall survival (OS) rate.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Collaborators

  • Dongying People's Hospital
  • Jining First People's Hospital
  • Liaocheng People's Hospital
  • Qianfoshan Hospital
  • Qilu Hospital of Shandong University
  • Rizhao People's Hospital
  • Shandong Provincial Hospital
  • Weifang Medical University
  • Weifang People's Hospital
  • Weihai Central Hospital
  • Weihai Municipal Hospital
  • Yantai Yuhuangding Hospital

Registry information

Official study title

Supervised Home-based Multimodal Prehabilitation to Improve the Clinical Outcomes of Frail Elderly Patients With Gastric Cancer: Multicenter Randomized Controlled Trial (GISSG+2201)

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Apr 29, 2022
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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