Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00213993
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Antiperspirant for Hand-Foot Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060831', 'term': 'Hand-Foot Syndrome'}], 'ancestors': [{'id': 'D003875', 'term': 'Drug Eruptions'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051520', 'term': 'Antiperspirants'}], 'ancestors': [{'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction in palm and/or sole pain', 'timeFrame': 'after each of first four cycles of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES)', 'timeFrame': 'after each of first four cycles of chemotherapy'}]}, 'conditionsModule': {'conditions': ['Palmar-plantar Erythrodysesthesia']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the effectiveness of an antiperspirant in preventing or attenuating the severity of palmer-plantar erythrodysesthesia associated with the Food and Drug Administration (FDA)-approved doses of capecitabine. The hypothesis is that cytotoxic compounds in sweat will be prevented from being deposited in the skin and causing chronic toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has not previously received a regimen that includes 5-fluorouracil\n* \\> 18 years old\n* No known allergy or intolerance to Ban Unscented Roll-On Antiperspirant\n\nExclusion Criteria:\n\n* \\< 18 years of age'}, 'identificationModule': {'nctId': 'NCT00213993', 'briefTitle': 'Topical Antiperspirant for Hand-Foot Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine', 'orgStudyIdInfo': {'id': '2002-0487'}, 'secondaryIdInfos': [{'id': 'CC-02308'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'antiperspirant topically to one foot once daily', 'interventionNames': ['Drug: antiperspirant']}], 'interventions': [{'name': 'antiperspirant', 'type': 'DRUG', 'description': 'antiperspirant topically once daily to one foot', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Paul R Hutson, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}