Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT06667427
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Adverse Events (AEs)', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "The goal of this research study is to measure changes in patients' quality of life after surgeries that affect the facial nerve, including nerve transfer as treatment for facial paralysis.", 'detailedDescription': 'Primary Objective:\n\nTo evaluate the impact of facial nerve transfer techniques (FNTT) on QoL in head and neck cancer patients with facial paralysis. This study intends to measure the impact of FNTT on QoL utilizing a series of validated questionnaires which include: (i) Facial Clinimetric Evaluation Scale and Facial Disability Index; (ii) Sunnybrook Facial Grading System; and (iii) Facial Nerve Grading Scale 2.0. These instruments will be administered at baseline, after surgery, and at 6, 12, and 18 months post-operatively.\n\nSecondary Objective:\n\nTo compare patient-reported outcomes and facial function scales for patients who undergo facial nerve transfer technique with a historical cohort of patients who did not undergo any dynamic nerve reconstruction procedures. The same assessment tools described in primary objective above will be utilized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible to participate in the intervention group of this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated informed consent form\n* Aged 18 or greater\n* Patient scheduled to undergo facial nerve transfer\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n\nIn order to be eligible to participate in the non-intervention historical control group of this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated informed consent form\n* Aged 18 or greater\n* Previous facial surgery severing a facial nerve without graft or other form of dynamic facial nerve reconstruction within the last 5 years\n\nExclusion Criteria:\n\nPatients known to be pregnant'}, 'identificationModule': {'nctId': 'NCT06667427', 'briefTitle': 'Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Pilot Study of Management of Facial Paralysis in the Oncologic Patient: Nerve Transfer Techniques to Improve Facial Function and Quality of Life', 'orgStudyIdInfo': {'id': '2024-1315'}, 'secondaryIdInfos': [{'id': 'NCI-2024-09091', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registray'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Participants will be identified and recruited during their visit to the Center of Reconstructive Surgery.', 'interventionNames': ['Procedure: Nerve transfer techniques']}, {'type': 'EXPERIMENTAL', 'label': 'Surgery', 'interventionNames': ['Procedure: Nerve transfer techniques']}], 'interventions': [{'name': 'Nerve transfer techniques', 'type': 'PROCEDURE', 'description': 'Participants will undergo facial nerve reconstruction using nerve transfer techniques', 'armGroupLabels': ['Control', 'Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Z-Hye Lee, MD', 'role': 'CONTACT', 'email': 'zlee@mdanderson.org', 'phone': '713-563-4598'}, {'name': 'Z-Hye Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas M. D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Z-Hye Lee, MD', 'role': 'CONTACT', 'email': 'zlee@mdanderson.org', 'phone': '713-563-4598'}], 'overallOfficials': [{'name': 'Z-Hye Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}