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

Qingdao University

Status: Not yet enrolling

Conditions: Neoadjuvant Therapy; Stomach Neoplasms

Treatments: Other: Standard Care; Behavioral: Family-supervised Multimodal Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07183358

QYFYEC2025-156

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Control Group (Standard Care Only)

Active Comparator group

Description:

Participants in this arm will receive standard neoadjuvant chemotherapy followed by radical gastrectomy, along with standard ERAS (Enhanced Recovery After Surgery) perioperative management. No prehabilitation intervention will be provided.

Treatment:

Other: Standard Care

Prehabilitation + Standard Care

Experimental group

Description:

Participants will receive a family-supervised multimodal prehabilitation program throughout the neoadjuvant chemotherapy period until the day before surgery. The intervention includes personalized nutritional support, home-based exercise training, and psychological counseling, in addition to standard neoadjuvant chemotherapy, surgery, and ERAS management.

Treatment:

Behavioral: Family-supervised Multimodal Prehabilitation