Effect of Family-Supervised Multimodal Prehabilitation Throughout Preoperative Neoadjuvant Chemotherapy on Clinical Outcomes in Gastric Cancer Patients: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of postoperative complications within 30 days after surgery
研究概览
简要总结
This study evaluates whether a family-supervised exercise-nutrition-psychology program can reduce complications after stomach-cancer surgery. Eligible patients are adults who will receive chemotherapy before surgery. Participants are randomly assigned to either the multimodal prehabilitation program plus usual care or usual care alone. The main outcome is the rate of serious complications within 30 days after surgery. Potential benefits include fewer complications and faster recovery; risks are minimal and mainly related to mild exercise fatigue.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Histologically proven gastric adenocarcinoma by gastroscopy
- •Clinical stage T2-4a, N any, M0 planned for neoadjuvant chemotherapy plus radical gastrectomy
- •ECOG performance status 0-1; ASA class I-III
- •Able to understand the study and provide signed informed consent
排除标准
- •Previous or concurrent malignancies
- •Emergent conditions (bleeding, perforation, obstruction) requiring immediate surgery
- •Pregnant or lactating women
- •Severe psychiatric disorders
- •Prior major abdominal surgery (except laparoscopic cholecystectomy)
- •Unstable angina, myocardial infarction, or cerebrovascular event within 6 months
- •Continuous use of NSAIDs, corticosteroids, or probiotics within 1 month
- •Simultaneous surgery for other diseases
- •FEV1 < 50 % predicted
- •Any condition that, in the investigator's opinion, contraindicates participation
研究组 & 干预措施
Prehabilitation + Standard Care
Participants will receive a family-supervised multimodal prehabilitation program throughout the neoadjuvant chemotherapy period until the day before surgery. The intervention includes personalized nutritional support, home-based exercise training, and psychological counseling, in addition to standard neoadjuvant chemotherapy, surgery, and ERAS management.
干预措施: Family-supervised Multimodal Prehabilitation (Behavioral)
Control Group (Standard Care Only)
Participants in this arm will receive standard neoadjuvant chemotherapy followed by radical gastrectomy, along with standard ERAS (Enhanced Recovery After Surgery) perioperative management. No prehabilitation intervention will be provided.
干预措施: Standard Care (Other)
结局指标
主要结局
Incidence of postoperative complications within 30 days after surgery
时间窗: Within 30 days after surgery
Postoperative complications include surgical site infection, anastomotic leakage, bleeding, pneumonia, urinary tract infection, and other surgery-related adverse events occurring within 30 days after radical gastrectomy.
次要结局
- Disease-free survival (DFS) at 6 months and 1 year(6 months and 1 year after surgery)
- Karnofsky Performance Status (KPS) score(Baseline, before surgery, and postoperative day 7)
- Intraoperative blood loss and operative time(Day of surgery)
- Length of postoperative hospital stay(Up to 30 days after surgery)
- Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression)(Baseline, before surgery, and postoperative day 7)
- Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight)(Baseline, before surgery, and postoperative day 7)
- Biological barrier: gut microbiota composition and diversity(Baseline, before surgery, and postoperative day 7)
- Chemical barrier: fecal MUC2 protein level and goblet cell density(Baseline, before surgery, and postoperative day 7)
- Immune barrier: fecal sIgA level and mucosal T-cell counts (CD3⁺, CD4⁺, CD8⁺)(Baseline, before surgery, and postoperative day 7)
研究者
Zhou Yanbing
Chief Physician, Affiliated Hospital of Qingdao University
The Affiliated Hospital of Qingdao University