Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 3:38 PM
Study NCT ID:
NCT00630695
Status:
COMPLETED
Last Update Posted:
2012-01-16
First Post:
2008-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008210', 'term': 'Lymphocele'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-13', 'studyFirstSubmitDate': '2008-02-27', 'studyFirstSubmitQcDate': '2008-02-27', 'lastUpdatePostDateStruct': {'date': '2012-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantity of lymph collected by the drain', 'timeFrame': 'D4 post operativly'}], 'secondaryOutcomes': [{'measure': 'Prevention of lymphocele', 'timeFrame': 'D15, D30 and M6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Axillary lymphocele breast cancer'], 'conditions': ['Lymphocele']}, 'descriptionModule': {'briefSummary': 'Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo. Evaluation of the lymphorrhea in the 2 arms of the study', 'detailedDescription': 'Patients will be recruited among patient refered to our department for a breast cancer and needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or placebo the day before surgery when they arrive in their room. The quantity of lymph in axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and M6 for pain, lymphocele and adverse events.\n\nData will be compared in the 2 groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patient (\\> 18 years),\n* Patient undergoing an axillary lymphadenectomy for breast cancer\n* Patient giving her agreement after being informed\n\nExclusion Criteria:\n\n* Patients that don't understand the trial\n* Type 2 diabetic patients\n* Cyclosporine treatment\n* Biliary lithiasis\n* Pregnancy or breast feeding\n* Allergic reaction to Lanréotide or same class treatments\n* Patient included in another trial within the last 30 days"}, 'identificationModule': {'nctId': 'NCT00630695', 'briefTitle': 'Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Evaluation of the Efficacity of Lanreotide LP 90 mg to Minimized the Lymphorrhea Post Axillary Lymphadenectomy in Breast Cancer', 'orgStudyIdInfo': {'id': '2007-003576-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lanreotide LP 90', 'interventionNames': ['Drug: Lanreotide LP 90']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo lanreotide']}], 'interventions': [{'name': 'Lanreotide LP 90', 'type': 'DRUG', 'description': 'Lanreotide LP 90', 'armGroupLabels': ['1']}, {'name': 'Placebo lanreotide', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hôpital Mère Enfant- CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}], 'overallOfficials': [{'name': 'Yves Aubard, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ipsen', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'CHU de Limoges', 'oldOrganization': 'CHU de Limoges'}}}}