Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-25 @ 8:32 AM
Study NCT ID:
NCT02741258
Status:
COMPLETED
Last Update Posted:
2022-07-05
First Post:
2016-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D063465', 'term': 'Skin Cream'}], 'ancestors': [{'id': 'D017592', 'term': 'Skin Care'}, {'id': 'D006920', 'term': 'Hygiene'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-30', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE)', 'timeFrame': 'one week after start of radiotherapy', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity'}], 'secondaryOutcomes': [{'measure': 'Time for the skin toxicity appearance and resolution', 'timeFrame': 'one week after start of radiotherapy'}, {'measure': 'Severity of the chronic skin toxicity', 'timeFrame': 'one week after start of radiotherapy', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v.4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post-surgery Radiotherapy']}, 'descriptionModule': {'briefSummary': 'This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer.\n\nMepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.', 'detailedDescription': "For patients randomized in the mepitel arm:\n\nMepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with mepitel.\n\nFor patients randomized in the standard of treatment arm:\n\nPatients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with breast cancer treated with conservative surgery who need radiotherapy treatment\n* capability and willness to participate to the study\n* informed consent form signature\n\nExclusion Criteria:\n\n* contraindication to the correct placement of the Mepitel Film\n* previous breast radiation treatment\n* participating in other clinical trials\n* previous breast reconstruction\n* concomitant treatment with antiblastic chemotherapy'}, 'identificationModule': {'nctId': 'NCT02741258', 'briefTitle': 'Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Oncology Institute of Southern Switzerland'}, 'officialTitle': 'Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer', 'orgStudyIdInfo': {'id': 'IOSI-INF-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mepitel Film', 'description': "Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with Mepitel.", 'interventionNames': ['Device: Mepitel Film']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Excipial U hydrolotion, Flammazin skin cream', 'description': 'Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine or Ialugen Plus) cream in case of skin erythema due to radiotherapy. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.', 'interventionNames': ['Drug: skin cream']}], 'interventions': [{'name': 'Mepitel Film', 'type': 'DEVICE', 'description': 'Placement of Mepitel Film to prevent skin toxicity', 'armGroupLabels': ['Mepitel Film']}, {'name': 'skin cream', 'type': 'DRUG', 'otherNames': ['Excipial U hydrolotion, Flammazin'], 'description': 'cream to treat skin erythema due to radiotherapy', 'armGroupLabels': ['Excipial U hydrolotion, Flammazin skin cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Oncology Institute of Southern Switzerland', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Institut für Radiotherapie Klinik Hirslanden', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Dario Valcarenghi', 'role': 'STUDY_CHAIR', 'affiliation': 'Oncology Institute of Southern Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not foreseen'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dario Valcarenghi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Nurse', 'investigatorFullName': 'Dario Valcarenghi', 'investigatorAffiliation': 'Oncology Institute of Southern Switzerland'}}}}