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NCT Number: NCT07201857

Peri-habilitation for Patients With Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer (Diagnosis) Digestive System Diseases Digestive System Neoplasms Disease Gastric Cancer Patient Gastric Cancer Patients Undergoing Gastrectomy Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nutrition education plus active supplement

Dietary 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.

Other names: Nutrition

Exercise

Behavioral

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.

Other names: Exercise and Nutrition

Primary outcomes

  1. Gait speed test

    Time frame: 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)

  2. Chair stand test

    Time frame: 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.

  3. Balance test

    Time frame: 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.

  4. Timed up and go test

    Time frame: 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 outcomes

  1. Electrocardiogram(ECG)

    Time frame: 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.

  2. Inflammation and Oxidative Stress Markers (Blood Analysis)

    Time frame: 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.

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  4. Quality of life(KOQUSS-32, KOQUSS-40)

    Time frame: 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.

  5. Clavien-dindo classification

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • Korea University

Registry information

Official study title

Peri-habilitation to Enhance Treatment Outcomes and Postoperative Recovery in Patients With Gastric Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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