Status:
RECRUITING
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Gastric Cancer
Prehabilitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Aged ≥18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2；
- Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma；
- The feasibility of neoadjuvant therapy was suggested by MDT, and the feasibility of radical gastrectomy was re-evaluated after neoadjuvant therapy;
- 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;
- The pregnancy test was negative within 1 month, and she was not pregnant or breastfeeding;
- Informed consent and ability to comply with research protocols.
Exclusion
- metastasis;
- 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 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;
- Patients have severe infections (such as MODS, etc.) or have allergic reactions to chemotherapy drugs and metabolic disorders;
- Concurrent tumors or other diseases requiring simultaneous surgery (except laparoscopic gallbladder surgery);
- Emergency surgery is required due to tumor complications (e.g., bleeding, perforation, obstruction);
- Patients participating in other clinical trials.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06521541
Start Date
June 1 2024
End Date
May 1 2025
Last Update
July 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, China, 266000