Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04481802
Status:
UNKNOWN
Last Update Posted:
2021-07-21
First Post:
2020-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011855', 'term': 'Radiodermatitis'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2020-06-07', 'studyFirstSubmitQcDate': '2020-07-19', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin assessment (RD grade)', 'timeFrame': '10 weeks', 'description': 'Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring'}, {'measure': 'Pain (VAS)', 'timeFrame': '10 weeks', 'description': 'Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment'}, {'measure': "Patient's assessment of the skin condition (DLQI questioner)", 'timeFrame': '10 weeks', 'description': 'The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation dermatitis', 'breast cancer'], 'conditions': ['Breast Cancer', 'Radiation Dermatitis']}, 'descriptionModule': {'briefSummary': 'Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT) and 95% of patients receiving RT may experience some form of radiation dermatitis.\n\nA wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation dermatitis but currently there is no gold standard in the prevention and management of this condition and no treatment can be explicitly recommended.\n\nRadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which provides optimal moist wound environment necessary to the healing process.\n\nBased on its composition as well as the supporting data on safety and performance of the functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement the prevention and therapy of radiation dermatitis.\n\nThe primary aim of the study is to evaluate the safety and performance of RadiaAce as compare to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or higher RD as measured by the RTOG scoring system'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patients\n2. Age \\> 18\n3. Patients with histologically-confirmed diagnosis of breast cancer\n4. Patients after breast lumpectomy and that scheduled to receive radiotherapy\n5. Patients to receive minimum of 40.05 Gy to primary field\n6. Must be able to comply with treatment schedule\n7. Study-specific signed informed consent prior to randomization\n\nExclusion Criteria:\n\n1. Inflammatory or connective tissue disorders of the skin\n2. Mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires\n3. Previous radiation therapy to the breast\n4. Tumour involvement of the skin\n5. Rash, ulceration or open wound in treatment field\n6. Known skin allergy or sensitivity to Aloe Vera or Biafine\n7. Current lactation\n8. Pregnancy\n9. Any other reason that, in the opinion of the investigator, prevents the subject from'}, 'identificationModule': {'nctId': 'NCT04481802', 'briefTitle': 'The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AceTech'}, 'officialTitle': 'The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'RadiaAce001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RadiaAce gel', 'description': 'RadiaAce Gel is a clear, non-oily Hydrogel wound dressing for the management of Radiation Dermatitis which provides optimal moist wound environment necessary to the healing process. RadiaAce gel contains Acemannan, a high molecular polysaccharide obtained from the inner gel of Aloe Vera leaves and it is considered the main functional component of Aloe vera (Sahu et al. 2013).', 'interventionNames': ['Device: RadiaAce gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biafine', 'description': 'one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.', 'interventionNames': ['Device: Biafine']}], 'interventions': [{'name': 'RadiaAce gel', 'type': 'DEVICE', 'otherNames': ['Acemannan hydrogel'], 'description': 'Patients will apply the RadiaAce to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.', 'armGroupLabels': ['RadiaAce gel']}, {'name': 'Biafine', 'type': 'DEVICE', 'description': 'Patients will apply the Biafine to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.', 'armGroupLabels': ['Biafine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'state': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hava Evelyn Klotz', 'role': 'CONTACT', 'email': 'havakl@assuta.co.il', 'phone': '+972-542196153'}], 'facility': 'Assuta', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Sivan Luder, VP R&D', 'role': 'CONTACT', 'email': 'Sivan@acemanan-tech.com', 'phone': '0508490794'}, {'name': 'Dana Shwartz, CA', 'role': 'CONTACT', 'email': 'dana@acemanan-tech.com', 'phone': '+972507509103'}], 'overallOfficials': [{'name': 'Meirav Ben David, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of radiotherapy Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AceTech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}