Peri-habilitation for Patients With Gastric Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorKorea University Anam Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Nutrition (NUT)Active comparator 1 intervention
Group B: Exercise and Nutrition(EN)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gait speed test

* Time to walk 4 meters (or 3 meters) at a normal, comfortable pace. * Seconds(sec) * Lower values(seconds) indicate better performance (faster walking speed)

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
2

Chair stand test

* Time to stand up and sit down 5 times from a chair without using the arms. * Seconds(sec) * Lower values(seconds) indicate better performance.

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
3

Balance test

* 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.

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
4

Timed up and go test

* 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.

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

Secondary outcomes

1

Electrocardiogram(ECG)

* Cardiovascular status assessed using electrocardiogram (ECG) * N/A (qualitative/clinical assessment) * Abnormal ECG findings indicate impaired cardiovascular function.

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
2

Inflammation and Oxidative Stress Markers (Blood Analysis)

* 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.

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
3

Hospital Anxiety and Depression Scale (HADS)

* 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.

Time frame
Baseline (2 weeks before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
4

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

* 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.

Time frame
Baseline (2 weeks before surgery) 3 weeks after discharge 6 months after surgery

Other outcomes

Sponsors and contacts

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Korea University Anam Hospital

Lead sponsor

Korea University

Collaborator

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