Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT01824134
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2013-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aloe Vera on Irradiated Breast Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2013-04-01', 'studyFirstSubmitQcDate': '2013-04-03', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'erythema', 'timeFrame': 'one year', 'description': 'since we are testing two over the counter products we wanted to wee if one tested better than the other'}], 'secondaryOutcomes': [{'measure': 'itching', 'timeFrame': 'one year', 'description': 'is there a difference in itching'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irradiated Breast Tissue']}, 'descriptionModule': {'briefSummary': 'The investigators are testing two over the counter aloe veras on irradiated breast tissue.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Women over 18 years of age who had undergone lumpectomy or partial mastectomy for breast cancer, and who then received postoperative radiation therapy using tangential fields, with or without a boost to the tumor bed. Chemotherapy as part of the treatment regimen was acceptable.\n2. No major medical or psychiatric illness that might interfere with patient's completion of study requirements\n3. Signed study-specific informed consent form prior to study entry\n\nExclusion Criteria:\n\n1. Those requiring nodal radiation therapy were excluded.\n2. Subjects who have a breast infection at the commencement of radiation treatment\n3. Before randomization, subjects who have agreed to participate are asked if they are allergic to any topical preparation. Those allergic to aloe vera were ineligible."}, 'identificationModule': {'nctId': 'NCT01824134', 'briefTitle': 'Aloe Vera on Irradiated Breast Tissue', 'organization': {'class': 'OTHER', 'fullName': 'John D. Archbold Memorial Hospital'}, 'officialTitle': 'A Phase III Double Blind Study on the Efficacy of Topical Aloe Vera Gel on Irradiated Breast Tissue', 'orgStudyIdInfo': {'id': '12-09-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Klean & Klear', 'description': 'aloe vera gel', 'interventionNames': ['Other: Klean & Klear The Dandy Day Corp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The Skin Gel', 'description': 'aloe vera gel', 'interventionNames': ['Other: The Skin Gel Herbal Answers, Inc']}], 'interventions': [{'name': 'Klean & Klear The Dandy Day Corp', 'type': 'OTHER', 'armGroupLabels': ['Klean & Klear']}, {'name': 'The Skin Gel Herbal Answers, Inc', 'type': 'OTHER', 'armGroupLabels': ['The Skin Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31792', 'city': 'Thomasville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital', 'geoPoint': {'lat': 30.83658, 'lon': -83.97878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John D. Archbold Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'J. Steven Johnson, MD', 'investigatorFullName': 'J. Steven Johnson, MD', 'investigatorAffiliation': 'John D. Archbold Memorial Hospital'}}}}