Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 6:52 AM
Study NCT ID:
NCT00445250
Status:
UNKNOWN
Last Update Posted:
2007-03-08
First Post:
2007-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Calcipotriol as Radioprotector of Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011855', 'term': 'Radiodermatitis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C055085', 'term': 'calcipotriene'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'lastUpdateSubmitDate': '2007-03-07', 'studyFirstSubmitDate': '2007-03-07', 'studyFirstSubmitQcDate': '2007-03-07', 'lastUpdatePostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of radiodermatitis'}], 'secondaryOutcomes': [{'measure': 'Side effects of Calcipotriol'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Calcipotriol', 'Breast', 'Cancer', 'Radiotherapy', 'Radiodermatitis in Breast Cancer'], 'conditions': ['Radiodermatitis']}, 'descriptionModule': {'briefSummary': 'Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast.\n\nTo check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications, allergies, weight, habits, size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.', 'detailedDescription': 'STUDY PROTOCOL\n\nFifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy, will participate in the study. About 15 minutes after receiving the daily radiation dose fraction, a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse. The other half of the breast will have a standard cream applied . During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy (e.g. strong erythema, painful tenderness etc.)The adverse skin effects will be assessed according to the following criteria:\n\n1. . an assessment by a physician and a nurse according to the RTOG score (6).\n\n As follows:\n\n Grade 0 - no reaction. Grade 1 - light erythema dry peeling, decrease in sweat production. Grade 3 - extensive moist peeling, pitting edema. Grade 4 - ulcers, bleeding and necrosis.\n2. . A questionnaire to each patient regarding the efficacy and safety of the cream.\n3. . Number of interruption of radiotherapy treatment. The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment.\n\nSafety report will be sent to the local independent ethics committee after the examination of the first ten patients.\n\nThe protective effect of the cream containing calcipotriol will be compared to the standard treatment and analyzed statistically using the parameters mention above. The relation between the background disease, medications, allergies, weight, habits, size of the irradiated breast, sun exposure, previous chemotherapy treatment and exposure to sunlight and the skin reaction will be evaluated.\n\nINCLUSION CRITERIA\n\n1. . Age ranging from 18 to 75.\n2. . Confirmed histological diagnosis of Breast cancer.\n3. . Radiotherapy treatment to the breast following lumpectomy.\n\nEXCLUSION CRITERIA\n\n1. . Scleroderma.\n2. . An extremely large breast. Interfiled above 25 cm.\n3. . Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.\n4. . Mastectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ranging from 18 to 75.\n2. Confirmed histological diagnosis of Breast cancer.\n3. Radiotherapy treatment to the breast following lumpectomy.\n\nExclusion Criteria:\n\n1. Scleroderma.\n2. An extremely large breast. Interfiled above 25 cm.\n3. Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is not a contraindication.\n4. Mastectomy.'}, 'identificationModule': {'nctId': 'NCT00445250', 'briefTitle': 'The Role of Calcipotriol as Radioprotector of Skin', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast.', 'orgStudyIdInfo': {'id': '004253'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calcipotriol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petach Tiqva', 'country': 'Israel', 'contacts': [{'name': 'Eyal Fenig, M.D.', 'role': 'CONTACT', 'email': 'efenig@clalit.org.il', 'phone': '97239377964'}, {'name': 'Ofer Purim, M.D.', 'role': 'CONTACT', 'email': 'oferp@clalit.org.il', 'phone': '97239377973'}, {'name': 'Eyal Fenig, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ofer Purim, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amir Abramovich, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rabin Medical Center'}], 'centralContacts': [{'name': 'Eyal Fenig, M.D.', 'role': 'CONTACT', 'email': 'efenig@clalit.org.il', 'phone': '97239377964'}, {'name': 'Ofer Purim, M.D.', 'role': 'CONTACT', 'email': 'oferp@clalit.org.il', 'phone': '97239377973'}], 'overallOfficials': [{'name': 'Eyal Fenig, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}}}}