Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Frail Elderly | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS protocol | Behavioral | — | UNRESOLVED |
| Multimodal prehabilitation program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prehabilitation group
- description
- The prehabilitation group received multimodal prehabilitation combined with ERAS before the gastrectomy.
- interventionNames
- Behavioral: Multimodal prehabilitation program
- Behavioral: ERAS protocol
- type
- ACTIVE_COMPARATOR
- label
- ERAS group
- description
- The ERAS group patients were treated according to the ERAS pathway.
- interventionNames
- Behavioral: ERAS protocol
Primary outcomes (1)
- measure
- The incidence and severity of postoperative complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDSun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Liu Q, Zhou Y. Supervised Multimodal Prehabilitation and Clinical Outcomes in Older Patients With Frailty and Gastric Cancer: The GISSG+2201 Randomized Clinical Trial. JAMA Surg. 2026 Mar 1;161(3):223-233. doi: 10.1001/jamasurg.2025.6256. PMID 41604182
- DERIVEDSun Y, Tian Y, Cao S, Li L, Yu W, Ding Y, Wang X, Kong Y, Wang X, Wang H, Hui X, Qu J, Wang H, Duan Q, Yang D, Zhang H, Zhou S, Liu X, Li Z, Meng C, Kehlet H, Zhou Y. Multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer: a study protocol for a multicentre randomised controlled trial (GISSG+2201). BMJ Open. 2023 Oct 10;13(10):e071714. doi: 10.1136/bmjopen-2023-071714. PMID 37816552