Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01822405
Status:
UNKNOWN
Last Update Posted:
2013-04-02
First Post:
2013-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-11-07', 'releaseDate': '2014-11-03'}], 'estimatedResultsFirstSubmitDate': '2014-11-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}, {'id': 'D024505', 'term': 'Tocopherols'}, {'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], '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'}, {'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-27', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-27', 'lastUpdatePostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in skin fibrosis measured by MRI', 'timeFrame': 'From baseline to 6 month of starting treatment', 'description': 'The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)'}], 'secondaryOutcomes': [{'measure': 'Clinical assessment of the radiation late (delayed) toxicity for mucosal membranes, salivary glands, larynx and skin by the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale)', 'timeFrame': 'Baseline and 6 months', 'description': 'The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)'}]}, 'conditionsModule': {'conditions': ['Fibrosis']}, 'descriptionModule': {'briefSummary': 'The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.\n\nHyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.', 'detailedDescription': 'Patients with head and neck tumors often present superficial radiation induced fibrosis and other late complications of radiotherapy that can seriously affect their quality of life.\n\nThe pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.\n\nHyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.\n\nBoth treatments in combination could produce a synergistic effect because the angiogenesis induced by hyperbaric oxygen therapy allow better access to drugs to the injury. The magnetic resonance, provides data of the fibrosis and other side effects of radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 18 years and under 70 years old.\n2. Patients who have received radiotherapy after being diagnosed with cancer of upper aerodigestive tract, and have skin toxicity grade II or higher.\n3. Follow-up for at least a year after the radiation treatment is completed.\n4. Absence of tumor at the time of recruitment.\n5. Patients with the capacity to give informed consent\n\nExclusion Criteria:\n\n1. Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).\n2. Patients taking oral anticoagulants (acenocoumarol, warfarin).\n3. Known hemorrhagic/coagulation disorder.\n4. Vitamin K deficiency due to any cause.\n5. Use of estrogens oral contraceptives.\n6. Serious bleeding or extensive retinal hemorrhage.\n7. Ischaemic heart diseases, including recent Myocardial Infarction.\n8. Serious cardiac arrhythmia.\n9. Severe liver disease.\n10. Severe renal failure (creatinine clearance \\<30 mL/min).\n11. Hypotension.\n12. Patients with metal objects or electronic devices such as cardiac pacemakers, artificial heart valves or cochlear implants, or any other contraindication for MRI\n13. Contraindication for Hyperbaric oxygen therapy.\n14. Patients with mobility problems.\n15. Female patients who are pregnant or lactating\n16. Any other situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.'}, 'identificationModule': {'nctId': 'NCT01822405', 'acronym': 'ORT-OXI-2009', 'briefTitle': 'Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario de Canarias'}, 'officialTitle': 'Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen', 'orgStudyIdInfo': {'id': 'ORT-OXI-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pentoxifylline + Tocopherol', 'description': 'Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months', 'interventionNames': ['Drug: pentoxifylline with tocopherol']}, {'type': 'EXPERIMENTAL', 'label': 'pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy', 'interventionNames': ['Other: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy']}], 'interventions': [{'name': 'pentoxifylline with tocopherol', 'type': 'DRUG', 'description': 'Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months', 'armGroupLabels': ['Pentoxifylline + Tocopherol']}, {'name': 'pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy', 'type': 'OTHER', 'description': 'pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day, oral during 6 months.\n\nHyperbaric Oxygen Therapy at 100% in 25 sessions of 90 minutes 5 days per week (5 weeks) at 2,4 Ata in Hyperbaric chamber, starting in 3 or 9 weeks after randomization and beginning of drug treatment.', 'armGroupLabels': ['pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'state': 'S/C de Tenerife', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Claudio Otón, MD', 'role': 'CONTACT', 'email': 'coton@ull.es'}, {'name': 'Claudio Otón, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}], 'centralContacts': [{'name': 'Claudio Otón, MD', 'role': 'CONTACT', 'email': 'coton@ull.es'}], 'overallOfficials': [{'name': 'Claudio Otón, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Canarias'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario de Canarias', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Médico Tinerfeño IMETISA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-11-03', 'type': 'RELEASE'}, {'date': '2014-11-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hospital Universitario de Canarias'}}}}