Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 4:15 AM
Study NCT ID:
NCT07374835
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-29
First Post:
2026-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema After Gynecologic Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-17', 'size': 273647, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2026-01-20T23:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method)', 'timeFrame': 'Baseline (before intervention), 12 weeks after intervention initiation', 'description': 'Limb volume change will be calculated using circumferential measurements of the lower extremity (ankle, calf, thigh) to quantify the reduction in lymphedema severity after intervention.'}, {'measure': 'Change in Lower Extremity Lymphedema Volume (measured by circumferential measurement) from baseline to 12 weeks after intervention', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Limb volume change will be calculated using circumferential measurements of the lower extremity to assess the efficacy of the intervention in reducing lymphedema.'}], 'secondaryOutcomes': [{'measure': 'Change in Limb Function Score (using the Lymphoedema Functioning, Disability and Health Questionnaire, LYMPH-Q) from baseline to 12 weeks', 'timeFrame': 'baseline to 12 weeks'}, {'measure': 'Change in Quality of Life Score (using the European Organization for Research and Treatment of Cancer QLQ-C30) from baseline to 12 weeks', 'timeFrame': 'baseline to 12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gynecologic Cancer Surgery', 'Lower Extremity Lymphedema', 'BMI Stratified Management', 'Meridian-Lymph Axis Theory'], 'conditions': ['Lower Extremity Lymphedema After Gynecologic Cancer Surgery']}, 'descriptionModule': {'briefSummary': "This study aims to investigate the impact of a BMI-stratified intervention program based on the meridian-lymphatic axis theory on the incidence of lower extremity lymphedema in postoperative patients with gynecological malignant tumors at 1 month, 3 months, and 6 months, and to validate the precision and effectiveness of this program compared to traditional CDT. Primary objectives: to evaluate the effects of this program on reducing the incidence of lymphedema, alleviating lymphedema-related symptoms (assessed via GCLQ score), improving patients' quality of life (assessed via LLQoL score), and enhancing patients' self-management behaviors."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Female patients aged 18-75 years who have undergone gynecologic cancer surgery (including hysterectomy, oophorectomy, or lymphadenectomy).\n\nDiagnosed with lower extremity lymphedema (stage I-II) within 6 months to 2 years post-surgery, confirmed by circumferential measurement.\n\nBMI between 18.5 and 35.0 kg/m². Able to understand and sign the informed consent form, and comply with the intervention and follow-up schedule.\n\nNo history of severe cardiovascular, renal, or hepatic dysfunction that would interfere with study participation.\n\n\\-\n\nExclusion Criteria:Patients with lower extremity lymphedema caused by other etiologies (e.g., trauma, infection, or congenital lymphedema).\n\nHistory of lower extremity surgery or fracture within 3 months prior to enrollment.\n\nActive infection or skin ulceration in the affected lower extremity. Participation in other clinical trials involving lymphedema interventions within the past 3 months.\n\nPregnancy or lactation during the study period. Inability to complete the intervention or follow-up due to cognitive or mobility impairment.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07374835', 'acronym': 'MLA-BMI-LLE', 'briefTitle': 'BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema After Gynecologic Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'BMI Stratified Management Based on Meridian-Lymph Axis Theory for Lower Extremity Lymphedema in Patients After Gynecologic Cancer Surgery', 'orgStudyIdInfo': {'id': 'TJ-IRB202512073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMI Stratified Management Group', 'description': 'Participants receive personalized management based on BMI, combining meridian conditioning and lymphatic circulation interventions.', 'interventionNames': ['Other: Meridian-Lymph Axis Based BMI Stratified Management']}, {'type': 'OTHER', 'label': 'Routine Care Control Group', 'description': 'Participants receive standard lymphatic edema care (e.g., compression garments, basic exercise guidance).', 'interventionNames': ['Other: Routine Lymphatic Edema Care']}], 'interventions': [{'name': 'Meridian-Lymph Axis Based BMI Stratified Management', 'type': 'OTHER', 'description': 'Personalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI.', 'armGroupLabels': ['BMI Stratified Management Group']}, {'name': 'Routine Lymphatic Edema Care', 'type': 'OTHER', 'description': 'Standard care including compression garment use, limb elevation, and basic exercise guidance.', 'armGroupLabels': ['Routine Care Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Nurse', 'investigatorFullName': 'Hong Zhang', 'investigatorAffiliation': 'Tongji Hospital'}}}}