Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 11:42 AM
Study NCT ID:
NCT01609166
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2012-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Allopurinol Topical Agent Prevention Capecitabine-induced 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': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-22', 'studyFirstSubmitDate': '2012-05-24', 'studyFirstSubmitQcDate': '2012-05-29', 'lastUpdatePostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the signs of hand-foot syndrome', 'timeFrame': 'At 1-2-3-4-5-6 months', 'description': 'Erythema, descamation, vesiculation'}], 'secondaryOutcomes': [{'measure': 'Changes in the symptoms of hand-foot syndrome', 'timeFrame': 'At 1-2-3-4-5-6 months', 'description': 'Burning, prurigo'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hand-foot Syndrome', 'capecitabine', 'allopurinol'], 'conditions': ['Hand-foot Syndrome']}, 'descriptionModule': {'briefSummary': 'Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial is conducted on the basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS.\n\nA randomized, double-blind phase III trial will evaluate 40 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be applied to the hands and feet twice per day for 6 months after the start of capecitabine. Patients will be examined every month and the investigators will take some photographs of hands and feet. HFS toxicity grade (Common Terminology Criteria for Adverse Events \\[CTCAE\\]v3.0) will be also collected at baseline and at the end of each cycle. The primary end point is the incidence of moderate/severe HFS symptoms at the end of capecitabine treatment , based on the patient-reported dermatological exploration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18years-old,that initiate treatment with oral capecitabine, without signs of hand-feet syndrome toxicity.\n* Free acceptance to participate part in this clinical trial, with signature of the form of informed assent approved for the study, writing of the volunteer.\n\nExclusion Criteria:\n\n* Age lower than 18 years\n* Precedents of allergy, idiosyncrasy or hypersensitivity to the medicament.\n* Denial of the patient to sign the informed assent.\n* Any disorder or current / previous treatment that, in the opinion of the investigator, incapacitates the patient to take part in the study.'}, 'identificationModule': {'nctId': 'NCT01609166', 'briefTitle': 'Effectiveness Allopurinol Topical Agent Prevention Capecitabine-induced Hand-foot Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Placebo-controlled Trial to Determine the Effectiveness of a 3% Allopurinol-base Topical Agent for Prevention of Capecitabine-induced Hand-foot Syndrome', 'orgStudyIdInfo': {'id': 'IIB-ALO-2010-02'}, 'secondaryIdInfos': [{'id': '2010-022095-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allopurinol 3% cream', 'description': 'Allopurinol 3% cream in one side of the body', 'interventionNames': ['Drug: Allopurinol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cream', 'description': 'Placebo cream in the other side of the body', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Allopurinol 3% cream application in one side of the body, twice a day for 6 months', 'armGroupLabels': ['Allopurinol 3% cream']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo cream application in the other side of the body, twice a day for 6 months', 'armGroupLabels': ['Placebo cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}