Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:05 AM
Study NCT ID:
NCT07328633
Status:
COMPLETED
Last Update Posted:
2026-01-09
First Post:
2025-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation Plus ERAS in Gastric Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080482', 'term': 'Enhanced Recovery After Surgery'}, {'id': 'D002985', 'term': 'Clinical Protocols'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-27', 'size': 358433, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-01T22:48', 'hasProtocol': True}, {'date': '2024-07-27', 'size': 195671, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-01T04:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-26', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-12-26', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sex distribution', 'timeFrame': 'Baseline (day of enrollment)', 'description': 'Biological sex at enrollment Unit: n (%) - Male, Female'}, {'measure': 'Height', 'timeFrame': 'Baseline (day of enrollment)', 'description': 'Body height measured without shoes Unit: cm'}, {'measure': 'Weight', 'timeFrame': 'Baseline (day of enrollment)', 'description': 'Body weight measured in light indoor clothing Unit: kg'}, {'measure': 'ECOG performance status', 'timeFrame': 'Baseline (day of enrollment)', 'description': 'Eastern Cooperative Oncology Group performance score Unit: n (%) - scores 0, 1, 2'}, {'measure': 'Nutritional risk score (NRS 2002)', 'timeFrame': 'Baseline (day of enrollment)', 'description': 'Nutritional Risk Screening 2002 total score Unit: n (%) - \\<3 vs ≥3'}, {'measure': 'ASA physical status classification', 'timeFrame': 'Baseline (day of enrollment)', 'description': 'American Society of Anesthesiologists classification Unit: n (%) - classes 1, 2, 3'}, {'measure': 'Tumor diameter', 'timeFrame': 'Baseline (after neoadjuvant therapy, before surgery)', 'description': 'Maximum diameter of the primary tumor on pre-operative imaging Unit: cm'}, {'measure': 'Clinical T stage', 'timeFrame': 'Baseline (after neoadjuvant therapy, before surgery)', 'description': 'Clinical T category per AJCC 8th edition Unit: n (%) - cT2, cT3, cT4'}, {'measure': 'Clinical N stage', 'timeFrame': 'Baseline (after neoadjuvant therapy, before surgery)', 'description': 'Clinical N category per AJCC 8th edition Unit: n (%) - cN0, cN1, cN2, cN3'}, {'measure': 'Six-minute walk test distance', 'timeFrame': 'Baseline (after neoadjuvant therapy, before surgery)', 'description': 'Distance walked in 6 minutes on indoor flat track Unit: meters'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days.', 'description': 'Anxiety and depression symptoms assessed with the 14-item HADS questionnaire; total score 0-21, higher scores indicate greater symptom severity.\n\nUnit: score (0-21)'}, {'measure': 'Health-related quality of life (EORTC QLQ-C30)', 'timeFrame': 'From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days.', 'description': 'Assessed with the 30-item EORTC QLQ-C30 questionnaire; 15 domains (5 functional, 9 symptom/single-item, 1 global QoL). Raw scores are linearly transformed to 0-100 standard scores. Higher functional/global scores = better QoL; higher symptom scores = worse symptoms.\n\nUnit: score (0-100)'}], 'primaryOutcomes': [{'measure': 'Incidence of Postoperative Complications', 'timeFrame': 'Postoperative 30-day', 'description': 'The primary outcome measure is the incidence of postoperative complications within 30 days after surgery, assessed using the Clavien-Dindo classification system(CDC ≥ II).'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'Intra-operative', 'description': 'Time from skin incision to skin closure. Unit: minutes.'}, {'measure': 'Estimated blood loss', 'timeFrame': 'Intra-operative', 'description': 'Total volume of intra-operative blood loss. Unit: mL.'}, {'measure': 'Pathological ypT stage', 'timeFrame': 'At pathology review (within 2 week after surgery)', 'description': 'Tumour infiltration depth in the resection specimen according to AJCC 8th edition.\n\nUnit: n (%) - categories T0, T1, T2, T3, T4.'}, {'measure': 'Pathological ypN stage', 'timeFrame': 'At pathology review (within 2 week after surgery)', 'description': 'Number of metastatic lymph nodes in the resection specimen. Unit: n (%) - categories N0, N1, N2, N3.'}, {'measure': 'AJCC pathological TNM stage', 'timeFrame': 'At pathology review (within 2 week after surgery)', 'description': 'Combined pathological stage. Unit: n (%) - stages I, II, III.'}, {'measure': 'Tumour regression grade (TRG)', 'timeFrame': 'At pathology review (within 2 week after surgery)', 'description': 'Degree of tumour response to neoadjuvant therapy according to Mandard criteria. Unit: n (%) - grades 0, 1, 2, 3.'}, {'measure': 'Time to first flatus', 'timeFrame': 'Post-operative period (up to 30 days)', 'description': 'Interval from end of surgery to first rectal gas passage. Unit: days.'}, {'measure': 'Time to first liquid diet', 'timeFrame': 'Post-operative period (up to 30 days)', 'description': 'Interval from end of surgery to first tolerated liquid intake. Unit: days.'}, {'measure': 'Post-operative hospital stay', 'timeFrame': 'Post-operative period.', 'description': 'Interval from surgery to hospital discharge. Unit: days.'}, {'measure': 'Serum albumin level', 'timeFrame': 'Post-operative day 1,3,5.', 'description': 'Serum albumin measured post-operatively. Unit: g/L.'}, {'measure': 'Tumour differentiation', 'timeFrame': 'At pathology review (within 2 week after surgery)', 'description': 'Histological grade of the tumour. Unit: n (%) - well / moderate / poor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Cancer', 'Neoadjuvant Chemotherapy', 'Laparoscopic Gastrectomy', 'Robotic Surgery', 'Pre-habilitation', 'Enhanced Recovery After Surgery (ERAS)'], 'conditions': ['Gastric Cancer (GC)']}, 'referencesModule': {'references': [{'pmid': '23667204', 'type': 'RESULT', 'citation': "Ajani JA, Bentrem DJ, Besh S, D'Amico TA, Das P, Denlinger C, Fakih MG, Fuchs CS, Gerdes H, Glasgow RE, Hayman JA, Hofstetter WL, Ilson DH, Keswani RN, Kleinberg LR, Korn WM, Lockhart AC, Meredith K, Mulcahy MF, Orringer MB, Posey JA, Sasson AR, Scott WJ, Strong VE, Varghese TK Jr, Warren G, Washington MK, Willett C, Wright CD, McMillian NR, Sundar H; National Comprehensive Cancer Network. Gastric cancer, version 2.2013: featured updates to the NCCN Guidelines. J Natl Compr Canc Netw. 2013 May 1;11(5):531-46. doi: 10.6004/jnccn.2013.0070."}, {'pmid': '33538338', 'type': 'RESULT', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '33663942', 'type': 'RESULT', 'citation': 'Xing J, Wang Y, Shan F, Li S, Jia Y, Ying X, Zhang Y, Li Z, Ji J. Comparison of totally laparoscopic and laparoscopic assisted gastrectomy after neoadjuvant chemotherapy in locally advanced gastric cancer. Eur J Surg Oncol. 2021 Aug;47(8):2023-2030. doi: 10.1016/j.ejso.2021.02.002. Epub 2021 Feb 6.'}, {'pmid': '37072637', 'type': 'RESULT', 'citation': 'Zhong H, Liu X, Tian Y, Cao S, Li Z, Liu G, Sun Y, Zhang X, Han Z, Meng C, Jia Z, Wang Q, Zhou Y. Comparison of short- and long-term outcomes between laparoscopic and open gastrectomy for locally advanced gastric cancer following neoadjuvant chemotherapy: a propensity score matching analysis. Surg Endosc. 2023 Aug;37(8):5902-5915. doi: 10.1007/s00464-023-10052-7. Epub 2023 Apr 18.'}, {'pmid': '39566200', 'type': 'RESULT', 'citation': 'Liu G, Cao S, Liu X, Tian Y, Li Z, Sun Y, Zhong H, Wang K, Zhou Y. Short- and long-term outcomes following perioperative ERAS management in patients undergoing minimally invasive radical gastrectomy after neoadjuvant chemotherapy: A single-center retrospective propensity score matching study. Eur J Surg Oncol. 2025 Jan;51(1):109459. doi: 10.1016/j.ejso.2024.109459. Epub 2024 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the impact of pre-habilitation combined with Enhanced Recovery After Surgery (ERAS) versus ERAS perioperative management alone on clinical outcomes in patients with gastric cancer undergoing neoadjuvant chemotherapy and laparoscopic (robotic) gastrectomy. The study is a single-center, randomized controlled trial involving patients aged 18-75 years. Participants will be randomly assigned to either a pre-habilitation program plus ERAS or ERAS alone. The primary outcome is the incidence of postoperative complications within 30 days. Secondary outcomes include pathological data, surgical outcomes, patient-reported outcomes, and long-term survival rates.', 'detailedDescription': 'The study is designed as a prospective, single-center, randomized, open-label, controlled clinical trial to compare the effects of pre-habilitation combined with ERAS versus ERAS alone in patients undergoing laparoscopic (robotic) gastrectomy after neoadjuvant chemotherapy for gastric cancer. The study will enroll patients aged 18-75 years who are scheduled for laparoscopic (robotic) gastrectomy following neoadjuvant chemotherapy. Participants will be randomly assigned in a 1:1 ratio to either the pre-habilitation plus ERAS group or the ERAS group. The pre-habilitation program will include a 4-week intervention involving exercise, nutrition, and psychological support prior to surgery. The primary endpoint is the incidence of postoperative complications within 30 days, assessed using the Clavien-Dindo classification. Secondary endpoints include pathological characteristics, surgical outcomes, patient-reported outcomes, and long-term survival rates. Data will be collected from patient records and follow-up visits. Statistical analysis will be performed using SPSS 26.0 or later versions, with significance level set at α=0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:18-75 years\n* ECOG:0-2\n* ASA:I-III\n* Histologically confirmed gastric adenocarcinoma (cT3-4aN+M0)\n* Fit for radical surgery after MDT\n* Negative pregnancy test within one month\n* Non-pregnant or non-lactating\n\nExclusion Criteria:\n\n* Severe cardiac (LVEF\\<30% or NYHA IV)\n* Severe hepatic or renal dysfunction (Child-Pugh ≥10; CrCl\\<25 ml/min)\n* Recent cerebrovascular events\n* Concomitant tumors requiring surgery\n* Emergency surgery for tumor complications,\n* Severe infections'}, 'identificationModule': {'nctId': 'NCT07328633', 'briefTitle': 'Prehabilitation Plus ERAS in Gastric Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'Effect of Pre-habilitation Combined With Enhanced Recovery After Surgery (ERAS) Versus ERAS Perioperative Management on Clinical Outcomes of Laparoscopic (Robotic) Gastrectomy in Patients With Gastric Cancer Receiving Neoadjuvant Chemotherapy: A Single-center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'QYFYEC2025-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-habilitation + ERAS', 'description': 'Participants will undergo a 4-week pre-habilitation program including exercise, nutrition, and psychological support, followed by Enhanced Recovery After Surgery (ERAS) protocols.', 'interventionNames': ['Behavioral: Pre-habilitation Program', 'Procedure: Enhanced Recovery After Surgery (ERAS) Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ERAS Only', 'description': 'Participants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program.', 'interventionNames': ['Procedure: Enhanced Recovery After Surgery (ERAS) Protocol']}], 'interventions': [{'name': 'Pre-habilitation Program', 'type': 'BEHAVIORAL', 'description': 'A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.', 'armGroupLabels': ['Pre-habilitation + ERAS']}, {'name': 'Enhanced Recovery After Surgery (ERAS) Protocol', 'type': 'PROCEDURE', 'description': 'Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.', 'armGroupLabels': ['ERAS Only', 'Pre-habilitation + ERAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266000', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}]}, 'ipdSharingStatementModule': {'url': 'https://pan.baidu.com/s/1T1f9IojYhtnVAkT8gLZryg', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Start date:Main results publication date. End date:5 years after publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) including baseline demographics, intervention details, and all primary/secondary outcomes will be shared. No participant identifiers will be included.', 'accessCriteria': 'Data will be available to qualified researchers upon reasonable request. Requests should be sent to 17866805578@163.com with a brief research proposal. A data-sharing agreement is required. Data will be provided in CSV format within 3 months of request approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Zhou Yanbing', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}