Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-27 @ 11:15 PM
Study NCT ID:
NCT03020251
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2016-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2016-12-20', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital length of stay after resection for lung cancer', 'timeFrame': 'time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days)', 'description': 'the date of discharge will be the real day of discharge from surgery department or the day where the patient will be medically considered as outgoing'}], 'secondaryOutcomes': [{'measure': 'the number of complications', 'timeFrame': 'during the stay in the surgery department or the intensive care unit (up to 56 days)'}, {'measure': 'peak oxygen consumption', 'timeFrame': 'evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)', 'description': 'evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).\n\nevaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)'}, {'measure': '6 minutes walking distance', 'timeFrame': 'evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)', 'description': 'evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).\n\nevaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)'}, {'measure': 'maximal voluntary quadriceps strength', 'timeFrame': 'evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)', 'description': 'evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).\n\nevaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)'}, {'measure': 'maximal inspiratory and expiratory strength', 'timeFrame': 'evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)', 'description': 'evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).\n\nevaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)'}, {'measure': 'real length of stay', 'timeFrame': 'between the first postoperative day (Day 1) and the real discharge date (up to 56 days)', 'description': 'the real day of discharge from surgery department'}, {'measure': 'body composition (bioimpedancemetry)', 'timeFrame': 'evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)', 'description': 'evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4).\n\nevaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)'}, {'measure': 'oxidative adaptations of the muscle', 'timeFrame': 'evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2 after intervention : at the date of surgery (during the surgical time at Day 0 week 6)', 'description': 'optional ancillary study on quadricipal and intercostal muscle biopsies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative rehabilitation program', 'chest physiotherapy', 'lung cancer resection'], 'conditions': ['Lungcancer']}, 'referencesModule': {'references': [{'pmid': '29133320', 'type': 'DERIVED', 'citation': 'Laurent H, Galvaing G, Thivat E, Coudeyre E, Aubreton S, Richard R, Kwiatkowski F, Costes F, Filaire M. Effect of an intensive 3-week preoperative home rehabilitation programme in patients with chronic obstructive pulmonary disease eligible for lung cancer surgery: a multicentre randomised controlled trial. BMJ Open. 2017 Nov 12;7(11):e017307. doi: 10.1136/bmjopen-2017-017307.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will evaluate the effect of a preoperative rehabilitation program at home in patients resected for lung cancer, comparing a control group (C group) receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a training program at home and chest physiotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed for lung cancer (or highly suspicious for cancer tumor) eligible for resection surgery (lobectomy or pneumonectomy)\n* Age \\> 18 years\n* Presence of Chronic Obstructive Pulmonary Disease (COPD) stages 2-4 of Gold (forced expiratory volume (FEV )/ forced vital capacity (FVC) \\<70%, FEV \\<80% of predicted) and Exertional dyspnea stage MMRC (Medical Research Council) \\> 1\n* Patients must provide written consent\n* Member of social security scheme\n\nExclusion Criteria:\n\n* Patients refusing to participate\n* COPD stage 1 Gold (VEMS \\>= 80% of the theoretical value)\n* Presenting an operating contraindication during the initial maximal exercise test\n* Presenting cardiac or vascular contraindication to achieve the readaptation program\n* Patient living alone at home\n* Patient with ventilatory assistance at home (oxygen therapy or noninvasive ventilation (NIV))\n* With exercise hypoventilation (PaCO2 \\>45 mmHg)\n* Cognitive difficulty\n* unable major\n* pregnancy,\n* patients deprived of liberty by a court or administrative decision'}, 'identificationModule': {'nctId': 'NCT03020251', 'acronym': 'Rexochir', 'briefTitle': 'Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Jean Perrin'}, 'officialTitle': 'Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer', 'orgStudyIdInfo': {'id': '2016-A00622-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group (C group)', 'description': 'patient will receive preoperative chest physiotherapy (standard supportive care)', 'interventionNames': ['Other: preoperative chest physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'rehabilitation group (R group)', 'description': 'patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)', 'interventionNames': ['Other: preoperative chest physiotherapy', 'Other: preoperative rehabilitation program']}], 'interventions': [{'name': 'preoperative chest physiotherapy', 'type': 'OTHER', 'description': 'preoperative chest physiotherapy : 5 sessions per week during 3 weeks', 'armGroupLabels': ['control group (C group)', 'rehabilitation group (R group)']}, {'name': 'preoperative rehabilitation program', 'type': 'OTHER', 'description': 'exercise training at home : 5 sessions per week during 3 weeks', 'armGroupLabels': ['rehabilitation group (R group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric Coste, MD', 'role': 'CONTACT'}, {'name': 'Frédéric Costes', 'role': 'CONTACT'}], 'facility': 'CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '63009', 'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ruddy Richard, Pr', 'role': 'CONTACT'}], 'facility': 'Centre de Recherche en Nutrition Humaine', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc Filaire, Pr', 'role': 'CONTACT', 'email': 'marc.filaire@cjp.fr', 'phone': '33 (0) 4 73 27 53 11'}, {'name': 'Marc Filaire, Pr', 'role': 'CONTACT'}], 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38700', 'city': 'Grenoble', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves Brichon, Pr', 'role': 'CONTACT'}], 'facility': 'CHU Grenoble, Hôpital Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69677', 'city': 'Lyon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'François Tronc, Pr', 'role': 'CONTACT'}], 'facility': 'Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42055', 'city': 'Saint-Etienne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Tiffet, Pr', 'role': 'CONTACT'}], 'facility': 'CHU Saint-Etienne, CHU Hopital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Marc FILAIRE, Pr', 'role': 'CONTACT', 'email': 'marc.filaire@clermont.unicancer.fr', 'phone': '33473278121'}], 'overallOfficials': [{'name': 'Marc FILAIRE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Jean Perrin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Jean Perrin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}