Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00925418
Status:
COMPLETED
Last Update Posted:
2011-09-14
First Post:
2009-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-13', 'studyFirstSubmitDate': '2009-06-19', 'studyFirstSubmitQcDate': '2009-06-19', 'lastUpdatePostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Number of day between inclusion and apparition of nail toxicity', 'timeFrame': '4 months'}, {'measure': 'Necessity of local care, existence of pains', 'timeFrame': '4 months'}, {'measure': 'Tolerance and compliance for the frozen glove', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neoplasm', 'breast Neoplasm', 'docetaxel', 'Glove'], 'conditions': ['Breast Neoplasms', 'Prostate Cancer', 'Nail Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.institutpaolicalmettes.fr', 'label': 'Official web site of the sponsor'}]}, 'descriptionModule': {'briefSummary': 'Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.\n\nPrimary objective:\n\nDemonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®.\n\nSecondary objectives:\n\nAnalysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hormono-resistant breast cancer or metastatic prostate cancer treated by chemotherapy with Taxotere®.\n* Patients aged 18 and older\n* Nail toxicity \\< grade 2 (CTC-AE version 3.0)\n* Informed patients with signed consent\n\nExclusion Criteria:\n\n* History of treatment with taxane\n* Raynaud syndrome\n* Distal metastasis in superior extremity\n* Nail diseases\n* Distal arteriopathy\n* Cold intolerance\n* Peripheral neuropathy\\>=2\n* Pregnancy, breast feeding\n* Unable to give informed consent\n* Unable to have a medical follow-up for social, geographical, family or psychological reasons'}, 'identificationModule': {'nctId': 'NCT00925418', 'acronym': 'CRYO1', 'briefTitle': 'Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.', 'orgStudyIdInfo': {'id': 'CRYO 1/IPC 2005-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Without Glove', 'description': 'Patients do not use frozen glove during chemotherapy with Taxotere®'}, {'type': 'EXPERIMENTAL', 'label': 'With Glove', 'description': 'Patients use frozen glove during chemotherapy with Taxotere®', 'interventionNames': ['Procedure: Frozen Glove']}], 'interventions': [{'name': 'Frozen Glove', 'type': 'PROCEDURE', 'description': 'Using frozen glove during chemotherapy with Taxotere®', 'armGroupLabels': ['With Glove']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'Institut PAOLI-CALMETTES', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Carole TARPIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}