Peri-habilitation for Patients With Gastric Cancer

NCT07201857 | Not Yet Recruiting

• 1 other identifier: KUMCANAM2025GES1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Keywords

peri-habilitation; gastric cancer; postoperative recovery; exercise intervention

Outcome Measures

Primary Outcomes (4)

• 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)

  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

• 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.

  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

• 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.

  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

• 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.

  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 (5)

• 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

• 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

• Hospital Anxiety and Depression Scale (HADS)

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

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

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

• Clavien-dindo classification

  Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery

Study Arms (2)

Nutrition (NUT)

ACTIVE COMPARATOR

Nutrition (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.

Dietary Supplement: nutrition education plus active supplement

Exercise and Nutrition(EN)

EXPERIMENTAL

Exercise and Nutrition Group (EN) Participants will receive peri-habilitation exercise training in combination 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.

Behavioral: Exercise

Interventions

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.

Also known as: Nutrition

Nutrition (NUT)

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.

Also known as: Exercise and Nutrition

Exercise and Nutrition(EN)

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Korea University: collaborator

Study Sites (1)

Anam Hospital

Seoul, seongbuk-gu, 02841, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Disease

Interventions

Nutrition Assessment; Nutritional Status; Exercise

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

KR (1)