Neoadjuvant Therapy, Stomach Neoplasms
Conditions
Keywords
prehabilitation, postoperative complications, multimodal, family-supervised, gastric cancer
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.
Interventions
BEHAVIORALFamily-supervised Multimodal Prehabilitation
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.
OTHERStandard Care
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.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative complications within 30 days after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight) | Baseline, before surgery, and postoperative day 7 | Assessment of nutritional markers and body weight changes during treatment. |
| Karnofsky Performance Status (KPS) score | Baseline, before surgery, and postoperative day 7 | A standardized measure of functional ability and general health status. |
| Intraoperative blood loss and operative time | Day of surgery | Total intraoperative blood loss (mL) and duration of surgery (minutes). |
| Length of postoperative hospital stay | Up to 30 days after surgery | Number of days from surgery to hospital discharge. |
| Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression) | Baseline, before surgery, and postoperative day 7 | Expression levels of tight junction proteins in intestinal mucosa, measured by immunohistochemistry or Western blot. |
| Biological barrier: gut microbiota composition and diversity | Baseline, before surgery, and postoperative day 7 | Fecal samples will be analyzed using 16S rRNA gene sequencing to evaluate microbial diversity and composition as indicators of the biological barrier. |
| Chemical barrier: fecal MUC2 protein level and goblet cell density | Baseline, before surgery, and postoperative day 7 | Fecal MUC2 concentration measured by ELISA and goblet cell density in small intestinal mucosa assessed by histopathological staining. |
| Immune barrier: fecal sIgA level and mucosal T-cell counts (CD3⁺, CD4⁺, CD8⁺) | Baseline, before surgery, and postoperative day 7 | Fecal secretory IgA (sIgA) measured by ELISA; mucosal CD3⁺, CD4⁺, and CD8⁺ T-cell densities evaluated by immunohistochemistry. |
| Disease-free survival (DFS) at 6 months and 1 year | 6 months and 1 year after surgery | Time from surgery to recurrence or death from any cause. |
Countries
China
Contacts
Primary ContactYanbing Zhou
Backup ContactYuanze Wei
Outcome results
None listed