Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 8:59 AM
Study NCT ID:
NCT07201857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peri-habilitation for Patients With Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}, {'id': 'D009752', 'term': 'Nutritional Status'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait speed test', 'timeFrame': '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', 'description': '* Time to walk 4 meters (or 3 meters) at a normal, comfortable pace.\n* Seconds(sec)\n* Lower values(seconds) indicate better performance (faster walking speed)'}, {'measure': 'Chair stand test', 'timeFrame': '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', 'description': '* Time to stand up and sit down 5 times from a chair without using the arms.\n* Seconds(sec)\n* Lower values(seconds) indicate better performance.'}, {'measure': 'Balance test', 'timeFrame': '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', 'description': '* Time maintaining balance in three positions (feet together, semi-tandem, and tandem stance). The maximum time allowed for each position is 10 seconds.\n* Seconds(sec)\n* Higher values(seconds) indicate better performance.'}, {'measure': 'Timed up and go test', 'timeFrame': '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', 'description': '* Time to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.\n* Seconds(sec)\n* Lower values(seconds) indicate better performance.'}], 'secondaryOutcomes': [{'measure': 'Electrocardiogram(ECG)', 'timeFrame': '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', 'description': '* Cardiovascular status assessed using electrocardiogram (ECG)\n* N/A (qualitative/clinical assessment)\n* Abnormal ECG findings indicate impaired cardiovascular function.'}, {'measure': 'Inflammation and Oxidative Stress Markers (Blood Analysis)', 'timeFrame': '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', 'description': '* Inflammatory and oxidative stress markers assessed by blood analysis, including C-reactive protein (CRP) and white blood cell(WBC) count.\n* mg/L for CRP; ×10⁹/L for WBC\n* Higher values indicate greater systemic inflammation.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline (2 weeks before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery', 'description': '* The scale ranges from 0 to 21 points for each domain (anxiety and depression). Higher scores indicate worse psychological distress.\n* Score on a scale (0-21)\n* Higher scores indicate worse psychological condition.'}, {'measure': 'Quality of life(KOQUSS-32, KOQUSS-40)', 'timeFrame': 'Baseline (2 weeks before surgery) 3 weeks after discharge 6 months after surgery', 'description': '* 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.\n* Score on a scale (range depends on quetionnaire)\n* Higher scores indicate better quality of life.'}, {'measure': 'Clavien-dindo classification', 'timeFrame': 'Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery', 'description': '* Postoperative complications will be assessed and graded according to the Clavien-Dindo classification system (Grade I-V).\n* Number of participants with each complication grade.\n* Higher grades indicate more severe postoperative complications.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peri-habilitation', 'gastric cancer', 'postoperative recovery', 'exercise intervention'], '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']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 65 years or older who have been diagnosed with gastric cancer and are scheduled to undergo surgical treatment or chemotherapy.\n\nExclusion Criteria:\n\n* Patients with severe conditions who are unable to undergo the intervention prior to surgical treatment or chemotherapy.\n* Patients with physical (e.g., musculoskeletal) or mental disorders that make participation in or continuation of the program impossible.\n* Patients judged to be at risk of additional physical burden from the intervention.'}, 'identificationModule': {'nctId': 'NCT07201857', 'briefTitle': 'Peri-habilitation for Patients With Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Peri-habilitation to Enhance Treatment Outcomes and Postoperative Recovery in Patients With Gastric Cancer', 'orgStudyIdInfo': {'id': 'KUMCANAM2025GES1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrition (NUT)', 'description': '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.', 'interventionNames': ['Dietary Supplement: nutrition education plus active supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise and Nutrition(EN)', 'description': 'Exercise and Nutrition Group (EN)\n\nParticipants 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.', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'nutrition education plus active supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutrition'], 'description': '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.', 'armGroupLabels': ['Nutrition (NUT)']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Exercise and Nutrition'], 'description': 'Exercise and Nutrition\n\nParticipants 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.', 'armGroupLabels': ['Exercise and Nutrition(EN)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02841', 'city': 'Seoul', 'state': 'seongbuk-gu', 'country': 'South Korea', 'contacts': [{'name': 'seokjun Cho, Ph.D student', 'role': 'CONTACT', 'email': 'zwx0209@korea.ac.kr', 'phone': '821040493206'}], 'facility': 'Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korea University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Min, Jae-Seok', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}