Clinical trial · Interventional
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy : A Single Center Randomized Control Trial
NCT06521541CI-TRIAL-00079152unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 intention of research is to establish a multimodal prehabilitation protocol in patients who undergo neoadjuvant chemotherapy prior to gastrectomy, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, fitness and long-term prognosis.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Prehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS program | Behavioral | — | UNRESOLVED |
| Multimodal prehabilitation program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multimodal prehabilitation group
- description
- Patients received multimodal prehabilitation combined with ERAS before the gastrectomy.
- interventionNames
- Behavioral: Multimodal prehabilitation program
- type
- ACTIVE_COMPARATOR
- label
- ERAS group
- description
- The ERAS pathway was followed in patients in the ERAS group.
- interventionNames
- Behavioral: ERAS program
Primary outcomes (1)
- measure
- Cardiopulmonary capacity
- timeFrame
- Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥18 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; 3. Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma; 4. The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of radical gastrectomy was re-evaluated after neoadjuvant therapy; 5. Blood routine, liver function, kidney function, heart function and lung function were normal before neoadjuvant therapy, and there was no contraindication of chemotherapy and surgery; 6. The pregnancy test was negative within 1 month, and she was not pregnant or breastfeeding; 7. Informed consent and ability to comply with research protocols. Exclusion Criteria: 1. metastasis; 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 hemorrhage, cerebral infarction, TIA or central nervous system disease or mental illness within 6 months, could not cooperate with the completion of neoadjuvant therapy and pre-rehabilitation exercise; 4. Patients have severe infections (such as MODS, etc.) or have allergic reactions to chemotherapy drugs and metabolic disorders; 5. Concurrent tumors or other diseases requiring simultaneous surgery (except laparoscopic gallbladder surgery); 6. Emergency surgery is required due to tumor complications (e.g., bleeding, perforation, obstruction); 7. Patients participating in other clinical trials.
References
Publications (1)
- DERIVEDLiu Q, Meng C, Cao S, Liu X, Tian Y, Li Z, Han L, Wang Q, Liu Z, Lv J, Liu N, Ji Q, Jiang Y, Han H, Zhao L, Niu Z, Jiang H, Sun Y, Liu G, Zhong H, Wang K, Zhou Y. The whole-course of supervised home-based multi-modal prehabilitation to improve clinical outcome in patients undergoing neoadjuvant chemotherapy prior to gastrectomy: a single-center randomized controlled trial. Gastric Cancer. 2026 May;29(3):669-679. doi: 10.1007/s10120-026-01735-w. Epub 2026 Mar 23. PMID 41870736