NCT06521541招募中不适用
Whole Course Multi-model Prehabilitation to Improve Clinical Outcome in Patients Undergoing Neoadjuvant Treatment Prior to Gastrectomy : A Single Center Randomized Control Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cardiopulmonary capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Multimodal prehabilitation group
Experimental
Patients received multimodal prehabilitation combined with ERAS before the gastrectomy.
干预措施: Multimodal prehabilitation program (Behavioral)
ERAS group
Active Comparator
The ERAS pathway was followed in patients in the ERAS group.
干预措施: ERAS program (Behavioral)
结局指标
主要结局
Cardiopulmonary capacity
时间窗: Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2)
The 6-minute walk test (6MWT) can be used to measure exercise capacity to reflect cardiopulmonary function.
次要结局
- Patient's quality of life(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
- Serum albumin levels(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
- First liquid diet(Postoperative (≤30 days after surgery))
- sarcopenia(Baseline (T0), Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks), and prior to surgery(T2))
- Duration of postoperative hospital stay(Postoperative (≤30 days after surgery))
- 3-year recurrence-free survival(3 years)
- 3-year overall survival(3 years)
- First exhaust and defecation(Postoperative (≤30 days after surgery))
- The incidence of postoperative complications(Postoperative (≤30 days after surgery))
- completetion of neoadjuvant chemotherapy(Post-neoadjuvant chemotherapy (through completetion of neoadjuvant therapy, an average of 16 weeks))
- Hospitalization costs(Postoperative (≤30 days after surgery))
研究者
研究点 (1)
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