Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer

Not Applicable

Not yet recruiting

• Conditions: Stomach Neoplasms; Neoadjuvant Therapy

• Registration Number: NCT07183358
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-13
• Study First Submitted QC: 2025-09-13
• Last Update Submitted: 2025-09-13
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-09-20
• Primary Completion: 2026-03-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Karnofsky Performance Status (KPS) score	Baseline, before surgery, and postoperative day 7	A standardized measure of functional ability and general health status.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Qingdao University Affiliated Hospital; 🇨🇳 Qingdao, Shandong, China