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

NCT07183358 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Stomach Neoplasms
  • Neoadjuvant Therapy

Interventions

BEHAVIORAL

Family-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.

OTHER

Standard 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 & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-20
Primary Completion
2026-03-20
Completion
2026-06-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07183358 on ClinicalTrials.gov