Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-26 @ 8:49 AM
Study NCT ID:
NCT00661102
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2008-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D010205', 'term': 'Pantothenic Acid'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015091', 'term': 'beta-Alanine'}, {'id': 'D000409', 'term': 'Alanine'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 598}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2008-04-16', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hand-foot syndrome onset', 'timeFrame': 'Event driven'}, {'measure': 'QoL C-30 score', 'timeFrame': 'Weeks 7, 13 and 17'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who have been receiving oral Xeloda for at least 5 days will be randomized to receive prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The anticipated time on study treatment is until disease progression or development of hand-foot syndrome, and the target sample size is 500+ individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* breast cancer or colorectal cancer patients;\n* treated with oral Xeloda for \\<=5 days;\n* lack of hand-foot syndrome (palmar-plantar erythrodysesthesia).\n\nExclusion Criteria:\n\n* existence of clinical symptoms suggesting hand-foot syndrome;\n* use of doxorubicin, 5-FU and/or cytarabine for last 3 months;\n* diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT00661102', 'briefTitle': 'A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.', 'orgStudyIdInfo': {'id': 'ML21419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: capecitabine [Xeloda]', 'Drug: dexpantenol [Bepantol]']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Corticosteroids', 'Drug: capecitabine [Xeloda]']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo', 'Drug: capecitabine [Xeloda]']}], 'interventions': [{'name': 'Corticosteroids', 'type': 'DRUG', 'description': 'As prescribed', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'As prescribed', 'armGroupLabels': ['3']}, {'name': 'capecitabine [Xeloda]', 'type': 'DRUG', 'description': 'As prescribed', 'armGroupLabels': ['1', '2', '3']}, {'name': 'dexpantenol [Bepantol]', 'type': 'DRUG', 'description': 'As prescribed', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60336-550', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '41810-570', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '40170-380', 'city': 'Salvador, Bahia', 'state': 'Estado de Bahia', 'country': 'Brazil'}, {'zip': '72115-700', 'city': 'Taguatinga', 'state': 'Federal District', 'country': 'Brazil', 'geoPoint': {'lat': -15.83326, 'lon': -48.05506}}, {'zip': '74605-020', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '74605-070', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '30150-320', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 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'country': 'Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '88301-220', 'city': 'Itajaí', 'state': 'Santa Catarina', 'country': 'Brazil', 'geoPoint': {'lat': -26.90778, 'lon': -48.66194}}, {'zip': '14784-400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '13083-888', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '17210-080', 'city': 'Jaú', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -22.29639, 'lon': -48.55778}}, {'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '09060-650', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '11075-350', 'city': 'Santos', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.96083, 'lon': -46.33361}}, {'zip': '11075-900', 'city': 'Santos', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.96083, 'lon': -46.33361}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '01221-020', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04026-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04039-901', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '22793-080', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '18030-005', 'city': 'Sorocaba', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}