Clinical trial NCT05352802: Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer
Official title: Supervised Home-based Multimodal Prehabilitation to Improve the Clinical Outcomes of Frail Elderly Patients With Gastric Cancer: Multicenter Randomized Controlled Trial (GISSG+2201)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stomach Neoplasms
Frail Elderly
Keywords: Multimodal prehabilitation
ERAS
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: Qilu Hospital of Shandong University
name: Qianfoshan Hospital
name: Yantai Yuhuangding Hospital
name: Jining First People's Hospital
name: Weifang Medical University
name: Weifang People's Hospital
name: Dongying People's Hospital
name: Weihai Municipal Hospital
name: Weihai Central Hospital
name: Rizhao People's Hospital
name: Liaocheng People's Hospital
First posted: 2022-04-29
Enrollment: 368
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: The incidence and severity of postoperative complications
timeFrame: Postoperative (≤30 days after surgery)
Secondary outcomes:
measure: Cardio-pulmonary function and physical capacity
timeFrame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
measure: Quality of life (QoL).
timeFrame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
measure: Detection of immune and inflammatory indicators
timeFrame: Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）
measure: The postoperative other observation parameters
timeFrame: Postoperative (≤30 days after surgery)
measure: Oncological outcomes
timeFrame: 3 years
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yanbing Zhou, MD
role: STUDY_DIRECTOR
References: