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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Affiliated Hospital of Qingdao University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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: 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 intervention

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Control Group (Standard Care Only)Active comparator 1 intervention
Group B: Prehabilitation + Standard CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Karnofsky Performance Status (KPS) score

A standardized measure of functional ability and general health status.

Time frame
Baseline, before surgery, and postoperative day 7
4

Intraoperative blood loss and operative time

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

Time frame
Day of surgery

Other outcomes

Sponsors and contacts

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