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NCT Number: NCT07183358

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

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.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoadjuvant Therapy Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Stomach Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family-supervised Multimodal Prehabilitation

Behavioral

A comprehensive prehabilitation program initiated at the start of neoadjuvant chemotherapy and continued until the day before surgery. The intervention includes:

  • Nutritional support: individualized dietary counseling and supplementation plans supervised by clinical nutritionists;
  • Exercise training: home-based aerobic and resistance exercises monitored via wearable devices and weekly video/phone follow-ups;
  • 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

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.

Primary outcomes

  1. 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

  1. Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression)

    Time frame: Baseline, before surgery, and postoperative day 7

    Expression levels of tight junction proteins in intestinal mucosa, measured by immunohistochemistry or Western blot.

  2. Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight)

    Time frame: Baseline, before surgery, and postoperative day 7

    Assessment of nutritional markers and body weight changes during treatment.

  3. Karnofsky Performance Status (KPS) score

    Time frame: Baseline, before surgery, and postoperative day 7

    A standardized measure of functional ability and general health status.

  4. Intraoperative blood loss and operative time

    Time frame: Day of surgery

    Total intraoperative blood loss (mL) and duration of surgery (minutes).

  5. Length of postoperative hospital stay

    Time frame: Up to 30 days after surgery

    Number of days from surgery to hospital discharge.

  6. Disease-free survival (DFS) at 6 months and 1 year

    Time frame: 6 months and 1 year after surgery

    Time from surgery to recurrence or death from any cause.

  7. Biological barrier: gut microbiota composition and diversity

    Time frame: 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.

  8. Chemical barrier: fecal MUC2 protein level and goblet cell density

    Time frame: 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.

  9. Immune barrier: fecal sIgA level and mucosal T-cell counts (CD3⁺, CD4⁺, CD8⁺)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanbing Zhou

CONTACT

[email protected]

+86532-82911847

Yuanze Wei

CONTACT

[email protected]

+8619861122261

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Effect of Family-Supervised Multimodal Prehabilitation Throughout Preoperative Neoadjuvant Chemotherapy on Clinical Outcomes in Gastric Cancer Patients: A Single-Center Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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