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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
A 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 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.
Qingdao University Affiliated Hospital
Qingdao, Shandong, China
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.
Time frame: Within 30 days after surgery
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.
Time frame: Baseline, before surgery, and postoperative day 7
Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight)
Assessment of nutritional markers and body weight changes during treatment.
Time frame: Baseline, before surgery, and postoperative day 7
Karnofsky Performance Status (KPS) score
A standardized measure of functional ability and general health status.
Time frame: Baseline, before surgery, and postoperative day 7
Intraoperative blood loss and operative time
Total intraoperative blood loss (mL) and duration of surgery (minutes).
Time frame: Day of surgery
Length of postoperative hospital stay
Number of days from surgery to hospital discharge.
Time frame: Up to 30 days after surgery
Disease-free survival (DFS) at 6 months and 1 year
Time from surgery to recurrence or death from any cause.
Time frame: 6 months and 1 year after surgery
Biological barrier: gut microbiota composition and diversity
Fecal samples will be analyzed using 16S rRNA gene sequencing to evaluate microbial diversity and composition as indicators of the biological barrier.
Time frame: Baseline, before surgery, and postoperative day 7
Chemical barrier: fecal MUC2 protein level and goblet cell density
Fecal MUC2 concentration measured by ELISA and goblet cell density in small intestinal mucosa assessed by histopathological staining.
Time frame: Baseline, before surgery, and postoperative day 7
Immune barrier: fecal sIgA level and mucosal T-cell counts (CD3⁺, CD4⁺, CD8⁺)
Fecal secretory IgA (sIgA) measured by ELISA; mucosal CD3⁺, CD4⁺, and CD8⁺ T-cell densities evaluated by immunohistochemistry.
Time frame: Baseline, before surgery, and postoperative day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.