Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:09 PM
Study NCT ID:
NCT07471451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution of Masticatory Function, Orofacial Functions and Quality of Life of Patients Treated for Cancers of the Upper Aerodigestive Tract, Rehabilitated by Maxillofacial Prostheses.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Particle size distribution of food bolus collected at the swallowing threshold', 'timeFrame': 'Baseline (T0) ; T1 (T0 + 3 months) ; T2 (T0 + 1 year)', 'description': 'Particle size distribution of food bolus collected at the swallowing threshold for raw carrot samples (CAR), objectified by the D50 value : median value of the particle size of each food bolus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mastication', 'chewing', 'cancer of the upper aerodigestive tract', 'prosthetic rehabilitation', 'oral-facial functions', 'quality of life', 'oral health', 'oral quality of life'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'This is a follow-up study of masticatory function, orofacial functions, and quality of life in patients with a history of upper aerodigestive tract cancer who have undergone rehabilitation with maxillofacial prostheses. The main objective of this study is to evaluate changes in masticatory function during a prosthetic rehabilitation program in patients with a history of upper aerodigestive tract cancer.', 'detailedDescription': "Patients are recruited and monitored within the maxillofacial prosthesis consultation of the Odontology Department at the Estaing University Hospital in Clermont - Ferrand. An objective assessment (clinical examination and functional tests) by a dentist, combined with a subjective assessment (questionnaires) by the patient, is carried out before and after maxillofacial prosthetic rehabilitation. The study includes three assessment periods : T0, before maxillofacial prosthetic rehabilitation ; T1, three months after prosthetic rehabilitation ; and T2, one year after prosthetic rehabilitation. Each evaluation stage includes an interview, a clinical examination, and functional tests. During the interview, patients are asked to complete questionnaires to assess their oral quality of life, dysphagia, orofacial functions, anxiety about treatment, and integration of their prostheses (from T1 onwards). The clinical examination assesses the patient's oral health (dental pattern, mandibular kinematics, occlusion) and tongue function (tongue mobility). Finally, the functional tests evaluate salivary function , chewing, and tongue strength. To study salivation, the patient is asked to spit their saliva into a container with or without prior stimulation, in order to measure salivary flow. For the chewing study, the patient must chew a test food (carrot) or chewing gum, which will be spat out for analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient who has given their consent\n* Patient with a history of upper aerodigestive tract cancer\n* Cooperative patient\n* Patient affiliated with a Social Security scheme\n* Patient capable of understanding and participating in the study\n* Patient not allergic to the foods being tested\n\nExclusion Criteria:\n\n* Minors\n* Patients treated in the maxillofacial prosthetics clinic of the Odontology Department at Estaing University Hospital in Clermont Ferrand who do not require prosthetic rehabilitation\n* Patients who are unwilling to participate in the study, particularly in attending the various follow-up sessions\n* Patients who do not have a good command of written and spoken French\n* Patients under guardianship, curatorship, or judicial protection\n* Pregnant or breastfeeding patients\n* Patients receiving enteral or parenteral nutrition\n* Patients who have been diagnosed with a recurrence of their cancer and whose prognosis is life-threatening.\n* Patients with cognitive impairment'}, 'identificationModule': {'nctId': 'NCT07471451', 'acronym': 'RMF-CROC', 'briefTitle': 'Evolution of Masticatory Function, Orofacial Functions and Quality of Life of Patients Treated for Cancers of the Upper Aerodigestive Tract, Rehabilitated by Maxillofacial Prostheses.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Evolution of Masticatory Function, Orofacial Functions and Quality of Life of Patients Treated for Cancers of the Upper Aerodigestive Tract, Rehabilitated by Maxillofacial Prostheses.', 'orgStudyIdInfo': {'id': 'RBHP 2025 BATISSE LANCE'}, 'secondaryIdInfos': [{'id': '2025-A02714-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prosthetic rehabilitation program', 'description': 'Patients with a history of upper aerodigestive tract cancer undergoing prosthetic oral rehabilitation aimed at restoring masticatory function. The evolution of masticatory function is assessed throughout the rehabilitation program.', 'interventionNames': ['Procedure: Prosthetic oral rehabilitation']}], 'interventions': [{'name': 'Prosthetic oral rehabilitation', 'type': 'PROCEDURE', 'description': 'Prosthetic oral rehabilitation to restore oral function in patients with a history of upper aerodigestive tract cancer.', 'armGroupLabels': ['Prosthetic rehabilitation program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'contacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+33473754963'}], 'facility': 'CHU de Clermont-Fd', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '+334.73.754.963'}], 'overallOfficials': [{'name': 'Cindy BATISSE LANCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Clermont-Fd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}