Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-18 @ 3:27 PM
Study NCT ID:
NCT02368457
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2015-02-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Management of Mandibular ORN: PENTO as Medical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010025', 'term': 'Osteoradionecrosis'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'D024505', 'term': 'Tocopherols'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'miryam.martos@gmail.com', 'phone': '+34932746179', 'title': 'Dr. Miriam Martos', 'organization': 'Oral and Maxillofacial Surgeon'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '18 months', 'eventGroups': [{'id': 'EG000', 'title': 'Pentoxifylline and Tocopherol', 'description': 'Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.\n\nPentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Standard treatment', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline and Tocopherol', 'description': 'Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.\n\nPentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard treatment'}], 'classes': [{'title': '1 month of starting treatment', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '18'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}]}]}, {'title': '3 month of starting treatment', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '16'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}]}]}, {'title': '6 month of starting treatment', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '13'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}]}]}, {'title': '9 month of starting treatment', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 1, 3, 6, and 9 months of starting treatment', 'description': 'Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).\n\nIntraoral bone exposure is measured in mm2.', 'unitOfMeasure': 'mm2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mean of intraoral bone exposure (measured in mm2) from baseline to 1, 3, 6, 9, 12 and 18 months of starting treatment'}, {'type': 'SECONDARY', 'title': 'Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pentoxifylline and Tocopherol', 'description': 'Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.\n\nPentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).'}, {'id': 'OG001', 'title': 'CONTROL', 'description': 'No drug treatment'}], 'classes': [{'title': '1 month of starting treatment', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '15.8'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '17'}]}]}, {'title': '3 month of starting treatment', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '15'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '17'}]}]}, {'title': '6 month of starting treatment', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '15'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '17'}]}]}, {'title': '9 month of starting treatment', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '14.6'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 1,3, 6, 9 months of starting treatment', 'description': 'Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).\n\nTo examine the LENT/SOMA scale prospectively using interviews and questionnaires\n\nAssessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.\n\nMaximum score: 36 Minimum score: 0\n\nQuestionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.\n\nScale categories:\n\nSubjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pentoxifylline and Tocopherol', 'description': 'Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.\n\nPentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'No drug treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pentoxifylline and Tocopherol', 'description': 'Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.\n\nPentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'No drug treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '10', 'groupId': 'BG000'}, {'value': '55', 'spread': '10', 'groupId': 'BG001'}, {'value': '56', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Exposed bone', 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '10', 'groupId': 'BG000'}, {'value': '15', 'spread': '10', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-24', 'studyFirstSubmitDate': '2015-02-10', 'resultsFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-25', 'studyFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).', 'timeFrame': 'From baseline to 1, 3, 6, and 9 months of starting treatment', 'description': 'Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).\n\nIntraoral bone exposure is measured in mm2.'}], 'secondaryOutcomes': [{'measure': 'Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale', 'timeFrame': 'From baseline to 1,3, 6, 9 months of starting treatment', 'description': 'Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).\n\nTo examine the LENT/SOMA scale prospectively using interviews and questionnaires\n\nAssessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.\n\nMaximum score: 36 Minimum score: 0\n\nQuestionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.\n\nScale categories:\n\nSubjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mandibular osteoradionecrosis', 'Tocopherol', 'pentoxifylline', 'vitamine E', 'wounds and injuries', 'antioxidants', 'free radical scavengers', 'radiation-protective agents', 'vasodilatadors agents', 'osteonecrosis', 'mandible', 'extraoral fistula', 'exposed bone', 'necrotic bone', 'head and neck radiotherapy'], 'conditions': ['Osteoradionecrosis']}, 'referencesModule': {'references': [{'pmid': '24993781', 'type': 'BACKGROUND', 'citation': 'Robard L, Louis MY, Blanchard D, Babin E, Delanian S. Medical treatment of osteoradionecrosis of the mandible by PENTOCLO: preliminary results. Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Dec;131(6):333-338. doi: 10.1016/j.anorl.2013.11.006. Epub 2014 Jun 30.'}, {'pmid': '20638190', 'type': 'BACKGROUND', 'citation': 'Delanian S, Chatel C, Porcher R, Depondt J, Lefaix JL. Complete restoration of refractory mandibular osteoradionecrosis by prolonged treatment with a pentoxifylline-tocopherol-clodronate combination (PENTOCLO): a phase II trial. Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):832-9. doi: 10.1016/j.ijrobp.2010.03.029. Epub 2010 Jul 16.'}, {'pmid': '15641107', 'type': 'BACKGROUND', 'citation': 'Delanian S, Depondt J, Lefaix JL. Major healing of refractory mandible osteoradionecrosis after treatment combining pentoxifylline and tocopherol: a phase II trial. Head Neck. 2005 Feb;27(2):114-23. doi: 10.1002/hed.20121.'}]}, 'descriptionModule': {'briefSummary': 'Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms.\n\nDifferent clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.', 'detailedDescription': 'Mandibular osteoradionecrosis which occurs after the use of radiation therapy for the treatment of head and neck cancer remains being the most problematic and irreversible complication despite its low incidence with no medical treatment to limit or reduce symptoms.\n\nClinical trials conducted to date have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis that have been irradiated based on the properties of this drugs in increased tissue oxygenation and their antioxidant effect.\n\nThe aim of this study is to determine if there is a clinical improvement of mandibular osteoradionecrosis using Pentoxifylline in combination with Tocopherol as treatment because, currently, there is no effective treatment to achieve bone healing and/or a symptomatic improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years and under 90 years old.\n* Patients who have received radiotherapy after being diagnosed with head and neck cancer and currently are diagnosticated of mandibular osteoradionecrosis (any clinical stage)\n* Follow-up for at least a year after the radiation treatment is completed.\n* Absence of tumor at the time of recruitment.\n* Patients with the capacity to give informed consent\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).\n* Patients taking oral anticoagulants (acenocoumarol, warfarin).\n* Known hemorrhagic/coagulation disorder.\n* Vitamin K deficiency due to any cause.\n* Use of estrogens oral contraceptives.\n* Serious bleeding or extensive retinal hemorrhage.\n* Ischaemic heart diseases, including recent Myocardial Infarction.\n* Serious cardiac arrhythmia.\n* Severe LIVER DISEASE.\n* Severe renal failure (creatinine clearance \\<30 mL/min).\n* Hypotension.\n* Female patients who are pregnant or lactating\n* Any other situation or condition that, in the opinion of the INVESTIGATOR, may interfere with optimal PARTICIPATION in the study.'}, 'identificationModule': {'nctId': 'NCT02368457', 'acronym': 'PENTO', 'briefTitle': 'Management of Mandibular ORN: PENTO as Medical Treatment', 'organization': {'class': 'OTHER', 'fullName': "Hospital Vall d'Hebron"}, 'officialTitle': 'Advances in the Management of Mandibular Osteoradionecrosis: Pentoxifylline and Tocopherol as Medical Treatment', 'orgStudyIdInfo': {'id': 'ORN-2014-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pentoxifylline and Tocopherol', 'description': 'Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.', 'interventionNames': ['Drug: Pentoxifylline and Tocopherol']}, {'type': 'NO_INTERVENTION', 'label': 'CONTROL', 'description': 'No drug treatment'}], 'interventions': [{'name': 'Pentoxifylline and Tocopherol', 'type': 'DRUG', 'otherNames': ['PENTO'], 'description': 'pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).', 'armGroupLabels': ['Pentoxifylline and Tocopherol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebrón Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Miriam Martos-Fernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Oral and Maxillofacial Surgery (Vall d'Hebrón Hospital)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Oral and Maxillofacial Surgeon', 'investigatorFullName': 'Miriam Martos-Fernandez', 'investigatorAffiliation': "Hospital Vall d'Hebron"}}}}