Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 12:41 PM
Study NCT ID:
NCT05663112
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2021-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Breast Massage Necessary to Find Sentinel Lymph Node?
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': 'D021701', 'term': 'Sentinel Lymph Node Biopsy'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008197', 'term': 'Lymph Node Excision'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'not necessary'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI\\>30 and age\\>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sentinel lymph node detection rate', 'timeFrame': '2 weeks', 'description': 'Participants will be followed until the pathology report is finalized'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'isosulfan blue', 'massage', 'sentinel lymph node', 'sentinel lymph node biopsy'], 'conditions': ['Sentinel Lymph Node', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '14965682', 'type': 'RESULT', 'citation': 'Shenoy V, Ravichandran D, Ralphs DN. Is massage following dye injection necessary in sentinel node biopsy in breast cancer? Breast. 2002 Jun;11(3):273-4. doi: 10.1054/brst.2002.0415.'}, {'pmid': '11192930', 'type': 'RESULT', 'citation': 'Bass SS, Cox CE, Salud CJ, Lyman GH, McCann C, Dupont E, Berman C, Reintgen DS. The effects of postinjection massage on the sensitivity of lymphatic mapping in breast cancer. J Am Coll Surg. 2001 Jan;192(1):9-16. doi: 10.1016/s1072-7515(00)00771-7.'}, {'pmid': '15614159', 'type': 'RESULT', 'citation': 'Diaz NM, Vrcel V, Centeno BA, Muro-Cacho C. Modes of benign mechanical transport of breast epithelial cells to axillary lymph nodes. Adv Anat Pathol. 2005 Jan;12(1):7-9. doi: 10.1097/01.pap.0000151267.34438.a1.'}], 'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/14965682/', 'label': 'Is massage following dye injection necessary in sentinel node biopsy in breast cancer?'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/11192930/', 'label': 'The Effects of Postinjection Massage on the Sensitivity of Lymphatic Mapping in Breast Cancer'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/15614159/', 'label': 'Modes of Benign Mechanical Transport of Breast Epithelial Cells to Axillary Lymph Nodes'}]}, 'descriptionModule': {'briefSummary': 'Sentinel lymph node biopsy is important for staging in patients with breast cancer and changes the way of surgery. One of the most commonly used methods to find the sentinel lymph node during surgery is to apply blue dye around the areola and then search for the sentinel lymph node. Breast massage is recommended following administration of the blue dye. However, the necessity of this massage is controversial. In this study, investigators will try to find out whether massage of the breast after blue dye injection has any positive effect on finding the sentinel lymph node.', 'detailedDescription': 'This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI\\>30 and age\\>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the diagnosis of breast cancer by biopsy\n* participants voluntarily participated in the clinical trial and signed informed consent\n\nExclusion Criteria:\n\n* had previous sentinel lymph node biopsy or axillary surgery\n* had neoadjuvant chemotherapy\n* had clinical hints of axillary lymph node metastasis'}, 'identificationModule': {'nctId': 'NCT05663112', 'briefTitle': 'Is Breast Massage Necessary to Find Sentinel Lymph Node?', 'organization': {'class': 'OTHER', 'fullName': 'Celal Bayar University'}, 'officialTitle': 'Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.', 'orgStudyIdInfo': {'id': '20.478.486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm with massage', 'description': '5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied.\n\nDrug: Isosulfan Blue 5 ml', 'interventionNames': ['Procedure: Sentinel lymph node biopsy', 'Procedure: Breast massage', 'Procedure: Blue dye injection']}, {'type': 'EXPERIMENTAL', 'label': 'Arm without massage', 'description': '5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied.\n\nDrug: Isosulfan Blue 5 ml', 'interventionNames': ['Procedure: Sentinel lymph node biopsy', 'Procedure: Blue dye injection']}], 'interventions': [{'name': 'Sentinel lymph node biopsy', 'type': 'PROCEDURE', 'description': 'Sentinel lymph node biopsy will be performed.', 'armGroupLabels': ['Arm with massage', 'Arm without massage']}, {'name': 'Breast massage', 'type': 'PROCEDURE', 'description': 'Breast massage will be performed for a duration of 5 minutes.', 'armGroupLabels': ['Arm with massage']}, {'name': 'Blue dye injection', 'type': 'PROCEDURE', 'description': 'Isosulfan blue dye will be injected in the subareolar region of the breast', 'armGroupLabels': ['Arm with massage', 'Arm without massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45030', 'city': 'Manisa', 'state': 'Yunusemre', 'country': 'Turkey (Türkiye)', 'facility': 'Celal Bayar University', 'geoPoint': {'lat': 38.61202, 'lon': 27.42647}}], 'overallOfficials': [{'name': 'Teoman Coskun, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celal Bayar University Department of General Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data sharing will not contribute to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celal Bayar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant, MD', 'investigatorFullName': 'Sezgi Erel', 'investigatorAffiliation': 'Celal Bayar University'}}}}