Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-31 @ 11:32 PM
Study NCT ID:
NCT04581005
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2020-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation in Esophageal Cancer Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2020-08-15', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen consumption (VO2)', 'timeFrame': 'Change from baseline to 2 months after surgery', 'description': 'Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)'}, {'measure': 'Oxygen consumption (VO2)', 'timeFrame': 'Change from baseline to post neo-adjuvant therapy (average duration 6-8 weeks)', 'description': 'Oxygen consumption at anaerobic threshold (VO2 at AT) measured with cardiopulmonary exercise testing (CPET)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'Prehabilitation utilizes the preoperative period to prevent or attenuate the treatment-related functional decline and its consequences. This project aims at testing feasibility and effectiveness of multimodal prehabilitation in esophageal cancer care.', 'detailedDescription': 'While evidence on prehabilitation is mounting, upper gastrointestinal surgery still remains under-investigated. This trial aims to explore the effect of prehabilitation over the whole perioperative trajectory, including neo-adjuvant treatment (NAT).\n\nMultimodal prehabilitation includes exercise, nutrition therapy, and mental distress coping strategies. In the context of a multimodal approach, the two groups follow different exercise prescriptions: high-intensity interval supervised training prescribed accordingly cardiopulmonary exercise testing (CPET)-derived variables, versus a home-based program. For both groups, multimodal prehabilitation is prescribed over the whole preoperative period, including during NAT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery.\n\nExclusion Criteria:\n\n* co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition'}, 'identificationModule': {'nctId': 'NCT04581005', 'briefTitle': 'Prehabilitation in Esophageal Cancer Care', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care', 'orgStudyIdInfo': {'id': 'MUHC 2019-5387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised Prehabilitation', 'description': 'Prehabilitation will include exercise, nutrition, and anxiety-coping intervention.\n\nThis group will receive a supervised, in-hospital training.', 'interventionNames': ['Behavioral: Prehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Home-based Prehabilitation', 'description': 'Prehabilitation will include exercise, nutrition, and anxiety-coping intervention.\n\nThis group will receive a home-based training.', 'interventionNames': ['Behavioral: Prehabilitation']}], 'interventions': [{'name': 'Prehabilitation', 'type': 'BEHAVIORAL', 'description': 'Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period', 'armGroupLabels': ['Home-based Prehabilitation', 'Supervised Prehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Francesco Carli, MD MPhil', 'role': 'CONTACT', 'email': 'franco.carli@mcgill.ca', 'phone': '5149341934', 'phoneExt': '43728'}, {'name': 'Enrico M Minnella, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Francesco Carli, MD MPhil', 'role': 'CONTACT', 'email': 'franco.carli@mcgill.ca', 'phone': '514-934-1934', 'phoneExt': '43274'}, {'name': 'Enrico M Minnella, MD PhD', 'role': 'CONTACT', 'email': 'enrico.minnella@mail.mcgill.ca', 'phone': '514-934-1934', 'phoneExt': '43274'}], 'overallOfficials': [{'name': 'Enrico M Minnella, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Franco Carli', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}