NCT05352802Active, not recruiting
Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer
Supervised Home-based Multimodal Prehabilitation to Improve the Clinical Outcomes of Frail Elderly Patients With Gastric Cancer: Multicenter Randomized Controlled Trial (GISSG+2201)
Source: ClinicalTrials.gov · Last updated 13 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 368 (actual)
- First submitted
- 18 Apr 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 13 Apr 2024
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05352802
What you commit to
- Study type: Interventional
- Participants enrolled: 368
- From 1 Sept 2022 to the primary completion date, 13 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with recurrent infection diseases or serious concomitant disease;
Other illness
- Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
- Cerebral bleeding or infarction (within 6 months);
- Patients who require synchronous surgery due to other illness;
- Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
Lab values
- 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;
Other
- Patients who are participating in any other clinical trials.
Who the study is looking for
- 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.
Age in the registry: 65 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.