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
The Affiliated Hospital of Qingdao University
90 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
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 measures and evaluate the effect of program on short-term clinical outcome, fitness and long-term prognosis.
Eligibility
Inclusion Criteria7
- 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 Criteria7
- 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.
Interventions
Patients adopted planned, structural, repetitive and purposeful approach that includes elements of exercise, nutritional and psychological.Patients were evaluated for changes during neoadjuvant therapy and postoperative recovery
The core content is to adopt a series of optimized measures performed during the perioperative period on the basis of evidence-based medical findings to reduce the physiological and psychological stress of patients and to accelerate their recovery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06521541