Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT07183358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], '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': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-13', 'studyFirstSubmitDate': '2025-09-13', 'studyFirstSubmitQcDate': '2025-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative complications within 30 days after surgery', 'timeFrame': 'Within 30 days after surgery', 'description': 'Postoperative complications include surgical site infection, anastomotic leakage, bleeding, pneumonia, urinary tract infection, and other surgery-related adverse events occurring within 30 days after radical gastrectomy.'}], 'secondaryOutcomes': [{'measure': 'Intestinal barrier function indicators (Claudin-1, Occludin, ZO-1 expression)', 'timeFrame': 'Baseline, before surgery, and postoperative day 7', 'description': 'Expression levels of tight junction proteins in intestinal mucosa, measured by immunohistochemistry or Western blot.'}, {'measure': 'Nutritional status (serum albumin, prealbumin, transferrin, hemoglobin, body weight)', 'timeFrame': 'Baseline, before surgery, and postoperative day 7', 'description': 'Assessment of nutritional markers and body weight changes during treatment.'}, {'measure': 'Karnofsky Performance Status (KPS) score', 'timeFrame': 'Baseline, before surgery, and postoperative day 7', 'description': 'A standardized measure of functional ability and general health status.'}, {'measure': 'Intraoperative blood loss and operative time', 'timeFrame': 'Day of surgery', 'description': 'Total intraoperative blood loss (mL) and duration of surgery (minutes).'}, {'measure': 'Length of postoperative hospital stay', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Number of days from surgery to hospital discharge.'}, {'measure': 'Disease-free survival (DFS) at 6 months and 1 year', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Time from surgery to recurrence or death from any cause.'}, {'measure': 'Biological barrier: gut microbiota composition and diversity', 'timeFrame': 'Baseline, before surgery, and postoperative day 7', 'description': 'Fecal samples will be analyzed using 16S rRNA gene sequencing to evaluate microbial diversity and composition as indicators of the biological barrier.'}, {'measure': 'Chemical barrier: fecal MUC2 protein level and goblet cell density', 'timeFrame': 'Baseline, before surgery, and postoperative day 7', 'description': 'Fecal MUC2 concentration measured by ELISA and goblet cell density in small intestinal mucosa assessed by histopathological staining.'}, {'measure': 'Immune barrier: fecal sIgA level and mucosal T-cell counts (CD3⁺, CD4⁺, CD8⁺)', 'timeFrame': 'Baseline, before surgery, and postoperative day 7', 'description': 'Fecal secretory IgA (sIgA) measured by ELISA; mucosal CD3⁺, CD4⁺, and CD8⁺ T-cell densities evaluated by immunohistochemistry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prehabilitation', 'postoperative complications', 'multimodal', 'family-supervised', 'gastric cancer'], 'conditions': ['Stomach Neoplasms', 'Neoadjuvant Therapy']}, 'referencesModule': {'references': [{'pmid': '33921433', 'type': 'BACKGROUND', 'citation': 'Golder HJ, Papalois V. Enhanced Recovery after Surgery: History, Key Advancements and Developments in Transplant Surgery. J Clin Med. 2021 Apr 12;10(8):1634. doi: 10.3390/jcm10081634.'}, {'pmid': '38677949', 'type': 'BACKGROUND', 'citation': 'Fleurent-Gregoire C, Burgess N, McIsaac DI, Chevalier S, Fiore JF Jr, Carli F, Levett D, Moore J, Grocott MP, Copeland R, Edbrooke L, Engel D, Testa GD, Denehy L, Gillis C. Towards a common definition of surgical prehabilitation: a scoping review of randomised trials. Br J Anaesth. 2024 Aug;133(2):305-315. doi: 10.1016/j.bja.2024.02.035. Epub 2024 Apr 26.'}, {'pmid': '26690252', 'type': 'BACKGROUND', 'citation': "Biondi A, Lirosi MC, D'Ugo D, Fico V, Ricci R, Santullo F, Rizzuto A, Cananzi FC, Persiani R. Neo-adjuvant chemo(radio)therapy in gastric cancer: Current status and future perspectives. World J Gastrointest Oncol. 2015 Dec 15;7(12):389-400. doi: 10.4251/wjgo.v7.i12.389."}, {'type': 'BACKGROUND', 'citation': 'Kang, Y.-K., Yook, J. H., Park, Y.-K., et al. (2019). Phase III randomized study of neoadjuvant chemotherapy (CT) with docetaxel (D), oxaliplatin (O) and S-1 (S) (DOS) followed by surgery and adjuvant S-1, vs surgery and adjuvant S-1, for resectable advanced gastric cancer (GC) (PRODIGY). Annals of Oncology, 30(10), 1637-1645.'}, {'pmid': '26487948', 'type': 'BACKGROUND', 'citation': 'Newton AD, Datta J, Loaiza-Bonilla A, Karakousis GC, Roses RE. Neoadjuvant therapy for gastric cancer: current evidence and future directions. J Gastrointest Oncol. 2015 Oct;6(5):534-43. doi: 10.3978/j.issn.2078-6891.2015.047.'}, {'pmid': '30207593', 'type': 'BACKGROUND', 'citation': 'Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates whether a family-supervised exercise-nutrition-psychology program can reduce complications after stomach-cancer surgery. Eligible patients are adults who will receive chemotherapy before surgery. Participants are randomly assigned to either the multimodal prehabilitation program plus usual care or usual care alone. The main outcome is the rate of serious complications within 30 days after surgery. Potential benefits include fewer complications and faster recovery; risks are minimal and mainly related to mild exercise fatigue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-80 years\n* Histologically proven gastric adenocarcinoma by gastroscopy\n* Clinical stage T2-4a, N any, M0 planned for neoadjuvant chemotherapy plus radical gastrectomy\n* ECOG performance status 0-1; ASA class I-III\n* Able to understand the study and provide signed informed consent\n\nExclusion Criteria:\n\n* Previous or concurrent malignancies\n* Emergent conditions (bleeding, perforation, obstruction) requiring immediate surgery\n* Pregnant or lactating women\n* Severe psychiatric disorders\n* Prior major abdominal surgery (except laparoscopic cholecystectomy)\n* Unstable angina, myocardial infarction, or cerebrovascular event within 6 months\n* Continuous use of NSAIDs, corticosteroids, or probiotics within 1 month\n* Simultaneous surgery for other diseases\n* FEV1 \\< 50 % predicted\n* Any condition that, in the investigator's opinion, contraindicates participation"}, 'identificationModule': {'nctId': 'NCT07183358', 'briefTitle': 'Family-Supervised Prehabilitation to Reduce Postoperative Complications After Neoadjuvant Chemotherapy in Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'Effect of Family-Supervised Multimodal Prehabilitation Throughout Preoperative Neoadjuvant Chemotherapy on Clinical Outcomes in Gastric Cancer Patients: A Single-Center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'QYFYEC2025-156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (Standard Care Only)', 'description': 'Participants in this arm will receive standard neoadjuvant chemotherapy followed by radical gastrectomy, along with standard ERAS (Enhanced Recovery After Surgery) perioperative management. No prehabilitation intervention will be provided.', 'interventionNames': ['Other: Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'Prehabilitation + Standard Care', 'description': 'Participants will receive a family-supervised multimodal prehabilitation program throughout the neoadjuvant chemotherapy period until the day before surgery. The intervention includes personalized nutritional support, home-based exercise training, and psychological counseling, in addition to standard neoadjuvant chemotherapy, surgery, and ERAS management.', 'interventionNames': ['Behavioral: Family-supervised Multimodal Prehabilitation']}], 'interventions': [{'name': 'Family-supervised Multimodal Prehabilitation', 'type': 'BEHAVIORAL', 'description': 'A comprehensive prehabilitation program initiated at the start of neoadjuvant chemotherapy and continued until the day before surgery. The intervention includes:\n\n1. Nutritional support: individualized dietary counseling and supplementation plans supervised by clinical nutritionists;\n2. Exercise training: home-based aerobic and resistance exercises monitored via wearable devices and weekly video/phone follow-ups;\n3. Psychological support: structured counseling sessions to reduce anxiety, improve treatment adherence, and enhance quality of life.\n\nFamily members are trained to assist with supervision and compliance. The total duration is approximately 10-16 weeks, depending on the chemotherapy schedule.', 'armGroupLabels': ['Prehabilitation + Standard Care']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Standard neoadjuvant chemotherapy followed by radical gastrectomy with standard ERAS-based perioperative management, without any additional prehabilitation intervention. Participants receive routine nutritional, nursing and medical care according to hospital guidelines. The aim is to maintain current clinical practice as the control condition for comparison with the experimental prehabilitation program.', 'armGroupLabels': ['Control Group (Standard Care Only)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266003', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Yanbing Zhou', 'role': 'CONTACT', 'email': 'zhouyanbing999@aliyun.com', 'phone': '+8653282911847'}, {'name': 'Yuanze Wei', 'role': 'CONTACT', 'email': 'weiyuanze4385@126.com', 'phone': '+8619861122261'}], 'facility': 'Qingdao University Affiliated Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Yanbing Zhou', 'role': 'CONTACT', 'email': 'zhouyanbing999@aliyun.com', 'phone': '+86532-82911847'}, {'name': 'Yuanze Wei', 'role': 'CONTACT', 'email': 'weiyuanze4385@126.com', 'phone': '+8619861122261'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician, Affiliated Hospital of Qingdao University', 'investigatorFullName': 'Zhou Yanbing', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}