Effect of Family-Supervised Multimodal Prehabilitation Throughout Preoperative Neoadjuvant Chemotherapy on Clinical Outcomes in Gastric Cancer Patients: A Single-Center Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Incidence of postoperative complications within 30 days after surgery
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Standard Care (Other)
Outcomes
Primary Outcomes
Incidence of postoperative complications within 30 days after surgery
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Zhou Yanbing
Chief Physician, Affiliated Hospital of Qingdao University
The Affiliated Hospital of Qingdao University