Peri-habilitation for Patients With Gastric Cancer

Not Applicable

Not yet recruiting

• Conditions: Gastric Cancer (Diagnosis); Gastric Cancer Patient; Gastric Cancer Patients Undergoing Gastrectomy; Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy; Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy

• Registration Number: NCT07201857
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

This study aims to evaluate the clinical applicability of a peri-habilitation program in patients with gastric cancer by applying nutritional intervention for approximately two weeks before surgery and a combined exercise and nutrition intervention for about three weeks after hospital discharge, and by analyzing its effects on the prevention of postoperative complications and recovery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2025-10-15
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients aged 65 years or older who have been diagnosed with gastric cancer and are scheduled to undergo surgical treatment or chemotherapy.

Exclusion Criteria

• Patients with severe conditions who are unable to undergo the intervention prior to surgical treatment or chemotherapy.
• Patients with physical (e.g., musculoskeletal) or mental disorders that make participation in or continuation of the program impossible.
• Patients judged to be at risk of additional physical burden from the intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait speed test	Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery	* Time to walk 4 meters (or 3 meters) at a normal, comfortable pace.; * Seconds(sec); * Lower values(seconds) indicate better performance (faster walking speed)
Chair stand test	Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery	* Time to stand up and sit down 5 times from a chair without using the arms.; * Seconds(sec); * Lower values(seconds) indicate better performance.
Balance test	Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery	* Time maintaining balance in three positions (feet together, semi-tandem, and tandem stance). The maximum time allowed for each position is 10 seconds.; * Seconds(sec); * Higher values(seconds) indicate better performance.
Timed up and go test	Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery	* Time to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.; * Seconds(sec); * Lower values(seconds) indicate better performance.

Secondary Outcome Measures

Name	Time	Method
Electrocardiogram(ECG)	Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery	* Cardiovascular status assessed using electrocardiogram (ECG); * N/A (qualitative/clinical assessment); * Abnormal ECG findings indicate impaired cardiovascular function.
Inflammation and Oxidative Stress Markers (Blood Analysis)	Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery	* Inflammatory and oxidative stress markers assessed by blood analysis, including C-reactive protein (CRP) and white blood cell(WBC) count.; * mg/L for CRP; ×10⁹/L for WBC; * Higher values indicate greater systemic inflammation.
Hospital Anxiety and Depression Scale (HADS)	Baseline (2 weeks before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery	* The scale ranges from 0 to 21 points for each domain (anxiety and depression). Higher scores indicate worse psychological distress.; * Score on a scale (0-21); * Higher scores indicate worse psychological condition.
Quality of life(KOQUSS-32, KOQUSS-40)	Baseline (2 weeks before surgery) 3 weeks after discharge 6 months after surgery	* Quality of life assessed using the Korean Quality of Life in Stomach Cancer Patient Study group questionnaires (KOQUSS-32 and KOQUSS-40). Each questionnaire provides domain-specific scores. Higher scores indicate better quality of life.; * Score on a scale (range depends on quetionnaire); * Higher scores indicate better quality of life.
Clavien-dindo classification	Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery	* Postoperative complications will be assessed and graded according to the Clavien-Dindo classification system (Grade I-V).; * Number of participants with each complication grade.; * Higher grades indicate more severe postoperative complications.

Trial Locations

Locations (1)

Anam Hospital; 🇰🇷 Seoul, seongbuk-gu, South Korea