Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT03961802
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2019-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)', 'timeFrame': '6 months postoperatively (M6)', 'description': 'The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.'}], 'secondaryOutcomes': [{'measure': 'Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)', 'timeFrame': '3 and 12 months postoperatively (M3 and M12)', 'description': 'The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.'}, {'measure': 'visual analog score for pain (M3, M6 and M12)', 'timeFrame': '3, 6 and 12 months postoperatively (M3, M6 and M12)', 'description': 'The reported score is between 0 and 10. The higher the score, the higher the pain.'}, {'measure': 'goniometric measurement of flexion and abduction of the shoulder', 'timeFrame': '3, 6 and 12 months postoperatively (M3, M6 and M12)', 'description': "Goniometric measurement will be performed using a Rippstein's Plurimeter, with standardized position and movement for each measurement:\n\n* Sitting on a chair, the bust is straight, arm hanging down the body.\n* The plurimeter is placed on the distal part of the arm.\n* The flexion is in the sagittal plane around a transverse axis in the frontal plane.\n* The abduction is in the frontal plane around an anteroposterior axis contained in the sagittal plane."}, {'measure': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)', 'timeFrame': '3, 6 and 12 months postoperatively (M3, M6 and M12)', 'description': 'EORTC QLQ-C30 questionnaire has 30 questions and includes the following scale:\n\n\\- health and overall quality of life, scale have a score between 0 and 100. A high score indicates the preservation of a good quality of life.'}, {'measure': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)', 'timeFrame': '3, 6 and 12 months postoperatively (M3, M6 and M12)', 'description': 'EORTC QLQ-C30 questionnaire has 30 questions and includes the following scale:\n\n\\- operating scale, scale have a score between 0 and 100. A high score for this scale indicates the preservation of a good quality of life.'}, {'measure': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)', 'timeFrame': '3, 6 and 12 months postoperatively (M3, M6 and M12)', 'description': 'EORTC QLQ-C30 questionnaire has 30 questions and includes the following scale:\n\n\\- scale of generic symptoms. scale have a score between 0 and 100. A high score for this scale indicates the presence of symptoms acting as factors of deterioration of certain aspects of the quality of life.'}, {'measure': 'European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck cancer module (H&N35)', 'timeFrame': '3, 6 and 12 months postoperatively (M3, M6 and M12)', 'description': 'EORTC QLQ-H\\&N35 questionnaire evaluates the specific symptoms of patients with head and neck cancers. It consists of 35 items including 7 subscales .\n\nsubscale scores are reported, All items and scales give a score between 0 and 100.\n\nFor each subscale, a high score indicates the presence of a large number of specific symptoms, acting as factors of deterioration of certain aspects of the quality of life.'}, {'measure': 'evaluate the compliance of patients to rehabilitation', 'timeFrame': '12 months postoperatively (M12)', 'description': '(% of rehabilitation sessions performed over 36 sessions)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'shoulder dysfunction', 'cervical lymph node dissection', 'head and neck cancer'], 'conditions': ['Rehabilitation']}, 'descriptionModule': {'briefSummary': 'A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.', 'detailedDescription': 'Pre-inclusion: information, collection of consent, collection of antecedents and biometric data, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ-C30 and H\\&N35 questionnaires.\n\nSurgical intervention (J0) and randomization into 2 groups:\n\nGroup 1 - systematic early rehabilitation Group 2 - without systematic rehabilitation\n\nM3, M6, M12: collection of complications, adjuvant treatments, number of physiotherapy sessions performed, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ- C30 and H\\&N35 questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proficiency in the oral and written French language\n* unilateral or bilateral cervical lymph node dissection preserving the accessory spinal nerve\n* Karnofsky index ≥ 80%\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* cognitive disorders\n* predictable difficulties in compliance with treatment and/or follow-up\n* pre-existing pathology involving shoulder and its mobility, independent of head and neck cancer\n* comorbidity preventing rehabilitation of the shoulder\n* time to start rehabilitation after 6 weeks postoperatively\n* pregnant women\n* minors\n* majors under guardianship\n* refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT03961802', 'acronym': 'RESYSTE', 'briefTitle': 'Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection', 'orgStudyIdInfo': {'id': 'RC17_0489'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'systematic early rehabilitation', 'description': 'systematic early rehabilitation', 'interventionNames': ['Other: sessions of shoulder rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'without systematic rehabilitation', 'description': 'without systematic rehabilitation'}], 'interventions': [{'name': 'sessions of shoulder rehabilitation', 'type': 'OTHER', 'description': '3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)', 'armGroupLabels': ['systematic early rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}