About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous or concurrent malignancies
Emergent conditions (bleeding, perforation, obstruction) requiring immediate surgery
Pregnant or lactating women
Severe psychiatric disorders
Trial design
Parallel
Treatments tested in this trial
Family-supervised Multimodal Prehabilitation
BehavioralA comprehensive prehabilitation program initiated at the start of neoadjuvant chemotherapy and continued until the day before surgery. The intervention includes: 1. Nutritional support: individualized dietary counseling and supplementation plans supervised by clinical nutritionists; 2. Exercise training: home-based aerobic and resistance exercises monitored via wearable devices and weekly video/phone follow-ups; 3. Psychological support: structured counseling sessions to reduce anxiety, improve treatment adherence, and enhance quality of life. Family members are trained to assist with supervision and compliance. The total duration is approximately 10-16 weeks, depending on the chemotherapy schedule.
Standard Care
Other interventionStandard neoadjuvant chemotherapy followed by radical gastrectomy with standard ERAS-based perioperative management, without any additional prehabilitation intervention. Participants receive routine nutritional, nursing and medical care according to hospital guidelines. The aim is to maintain current clinical practice as the control condition for comparison with the experimental prehabilitation program.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative complications 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
Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression)
Expression levels of tight junction proteins in intestinal mucosa, measured by immunohistochemistry or Western blot.
Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight)
Assessment of nutritional markers and body weight changes during treatment.
Karnofsky Performance Status (KPS) score
A standardized measure of functional ability and general health status.
Intraoperative blood loss and operative time
Total intraoperative blood loss (mL) and duration of surgery (minutes).
Sponsors and contacts
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