Gastric Cancer (Diagnosis), Gastric Cancer Patient, Gastric Cancer Patients Undergoing Gastrectomy, Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy, Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy
Conditions
Keywords
peri-habilitation, gastric cancer, postoperative recovery, exercise intervention
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.
Interventions
DIETARY_SUPPLEMENTnutrition education plus active supplement
Nutrition Group (NUT) Participants will receive standard clinical care combined with nutrition education and protein-enriched soy milk supplementation for approximately 2 weeks before surgery and about 3 weeks after hospital discharge.
BEHAVIORALExercise
Exercise and Nutrition Participants will receive peri-habilitation exercise training together with nutritional intervention, including carbohydrate plus protein-enriched soy milk supplementation twice daily (before and after exercise), for approximately 2 weeks before surgery and about 3 weeks after hospital discharge.
Sponsors
Korea University
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed