Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-27 @ 9:43 PM
Study NCT ID:
NCT06302361
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-14
First Post:
2024-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphovenous Anastomosis for Breast Cancer Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D000072656', 'term': 'Breast Cancer Lymphedema'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-07', 'size': 934504, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-04T05:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multi-center cohort study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm volume (Water Displacement)', 'timeFrame': 'Baseline, six months, twelve months', 'description': 'Changes of arm volume difference'}, {'measure': 'Arm volume (Arm Circumferences)', 'timeFrame': 'Baseline, six months, twelve months', 'description': 'Changes of arm volume difference'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life (LYMPH-Q)', 'timeFrame': 'baseline, three months, six months, nine months, twelve months', 'description': 'Changes of health-related quality of life, measured with LYMPH-Q'}, {'measure': 'General quality of life (SF-36)', 'timeFrame': 'baseline, three months, six months, nine months, twelve months', 'description': 'Changes of health-related quality of life measured with SF-36'}, {'measure': 'Arm and shoulder function (DASH)', 'timeFrame': 'baseline, three months, six months, nine months, twelve months', 'description': 'Changes in arm and shoulder function, measured with DASH'}, {'measure': 'L-Dex', 'timeFrame': 'Baseline, six months, twelve months', 'description': 'Changes in L-Dex score'}, {'measure': 'LVA patency', 'timeFrame': 'Baseline, six months', 'description': 'Evaluation of patency using indocyanine green lymphography postoperatively. Number of patent anastomosis will be compared to number performed during surgery.'}, {'measure': 'Skin Fibrosis', 'timeFrame': 'Baseline, six months, twelve months', 'description': 'The degree of skin fibrosis measured with SkinFibroMeter'}, {'measure': 'Surgery duration', 'timeFrame': 'Day of intervention', 'description': 'The duration of surgery will be compared between sites'}, {'measure': 'Body composition', 'timeFrame': 'Baseline, six months, twelve months', 'description': 'Changes in body compositions measured with SoZo bioimpedance will be evaluated.'}, {'measure': 'Skin Water Content', 'timeFrame': 'Baseline, six months, twelve months', 'description': 'The water content in the dermis measured with LymphScanner'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphedema', 'Lymphedema Arm', 'Breast Cancer Lymphedema', 'Lymphedema, Secondary', 'Lymphedema; Surgical', 'Lymphedema of Upper Limb', 'Lymphedema, Breast Cancer']}, 'descriptionModule': {'briefSummary': "This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.\n\nEligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.\n\nPatients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.\n\nThe study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.\n\nThe study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.", 'detailedDescription': "This comprehensive single-armed cohort study is dedicated to assessing the effectiveness of lymphovenous anastomosis (LVA) in treating pitting lymphedema among adult female patients who have undergone breast cancer treatment.\n\nThis study builds upon findings from our preliminary pilot study at Odense University Hospital, and is conducted across several hospitalt in Denmark, including Odense University Hospital, Lillebælt Hospital Vejle, Zealand University Hospital Roskilde, and Herlev Hospital.\n\nThe study's primary aim is to determine whether LVA can significantly reduce arm volume and improve the overall quality of life for patients afflicted with breast cancer-related lymphedema.\n\nInclusion Criteria and Patient Recruitment The study population consists of women over 18 years of age suffering from unilateral arm lymphedema secondary to breast cancer treatment. Key eligibility criteria include active pitting lymphedema, presence of dermal backflow as evidenced by indocyanine green lymphography, identifiable lymphatic vessels in the affected arm, and the ability to provide informed consent and complete questionnaires in Danish.\n\nProspective participants are identified during clinical assessments at the participating hospitals' Departments of Plastic Surgery. Those deemed suitable for LVA surgery by consulting surgeons are invited to participate, ensuring informed consent through both oral and written communication.\n\nMethod This multi-center cohort study employs a range of outcome measures to evaluate the impact of LVA surgery. Primary outcomes focus on changes in arm volume, measured through water displacement volumetry and arm circumferential measurements, employing the unaffected arm as a control.\n\nSecondary outcomes include assessments of body composition via bioimpedance spectroscopy, health-related quality of life through the LYMPH-Q questionnaire, arm function via the DASH questionnaire, general quality of life via the SF-36 questionnaire, patency of anastomosis validated by ICG lymphography, changes in ICG lymphography images, and arm fibrosis measured with the SkinFibroMeter.\n\nData collected are entered into a secure database for analysis. This includes comparing pre- and postoperative measurements to assess the primary and secondary outcomes.\n\nSurgical Procedure and Follow-up LVA surgeries are performed by surgeons at Odense University Hospital and Herlev Hospital, with the choice between local or general anesthesia based on the number of planned anastomoses and patient preference.\n\nPatients will be seen prior to surgery for baseline measurements, in addition to six and twelve months post-operative follow-up. At three and nine months post-operative, phone consultations will be performed for reminders of questionnaires and patient safety.\n\nThe study prohibits participants from undergoing other medical or surgical treatments for lymphedema during the trial period, although conservative treatments like compression garments are accepted.\n\nData Management and Ethics Adhering to the ethical standards, this study complies with Good Clinical Practice, The Danish Code of Conduct for Research Integrity, and GDPR. It has sought approval from the Research Ethics Committee of the Region of Southern Denmark. Patient safety is paramount, with LVA considered a safe and valid treatment option.\n\nFeasibility and Publication Led by Caroline Lilja, MD, and Ph.D. student, under the supervision of Jørn Bo Thomsen, Dr., MD., Ass. Prof., the study aims for results publication regardless of the outcome, emphasizing its contribution to the field and potential impact on treatment protocols for lymphedema patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18\n* Female\n* Unilateral arm lymphedema secondary to breast-cancer treatment\n* Active pitting lymphedema\n* Presence of dermal backflow in indocyanine green lymphography\n* Identifiable lymphatic vessel(s) in the affected arm using an infrared camera and indocyanin green\n* Able to provide informed consent\n* Able to read, understand and complete Danish questionnaires\n\nExclusion Criteria:\n\n* Allergy to iodine\n* Pregnant, breast-feeding, or aiming to conceive withing the next year\n* History of bilateral breast cancer'}, 'identificationModule': {'nctId': 'NCT06302361', 'briefTitle': 'Lymphovenous Anastomosis for Breast Cancer Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Lymphovenous Anastomosis for Breast Cancer-related Lymphedema: A Cohort Study', 'orgStudyIdInfo': {'id': '23/54225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lymphovenous anastomosis (LVA)', 'description': 'Intervention with lymphovenous anastomosis (LVA) surgery of the affected arm.', 'interventionNames': ['Procedure: Lymphovenous anastomosis (LVA)']}], 'interventions': [{'name': 'Lymphovenous anastomosis (LVA)', 'type': 'PROCEDURE', 'otherNames': ['Lymphovenous bypass', 'Lymphaticovenular anastomosis'], 'description': 'Surgical procedure with supermicrosurgical anastomosis between distal lymph vessel and proximal venule.', 'armGroupLabels': ['Lymphovenous anastomosis (LVA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Region Syddanmark', 'country': 'Denmark', 'facility': 'Department of Plastic Surgery, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Caroline Lilja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vejle Hospital', 'class': 'OTHER'}, {'name': 'Zealand University Hospital', 'class': 'OTHER'}, {'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Caroline Lilja', 'investigatorAffiliation': 'Odense University Hospital'}}}}