[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658683":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":39,"studyPopulation":29,"armGroups":40,"interventions":53,"overallOfficials":66,"centralContacts":71,"locations":77,"responsibleParty":94,"collaborators":29,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":29,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":29,"enrollmentInfo":106,"targetDuration":29,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":29,"overallStatus":79,"whyStopped":29,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Ankara City Hospital Bilkent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":29},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change in Upper-Extremity Circumference Difference","Circumference measurements will be obtained from both the affected and unaffected upper extremities, and the difference between the two extremities will be recorded.","Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.",{"measure":14,"description":15,"timeFrame":12},"Change in Upper-Extremity Volume","Upper-extremity volume will be calculated from serial circumference measurements using the truncated cone formula.",{"measure":17,"description":18,"timeFrame":12},"Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography","Skin and subcutaneous tissue thickness will be assessed ultrasonographically at the dorsum of the hand, forearm, and upper arm.",[20,23,26],{"measure":21,"description":22,"timeFrame":12},"Change in Upper-Extremity Function Assessed by the QuickDASH","Upper-extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.",{"measure":24,"description":25,"timeFrame":12},"Change in Lymphedema-Related Quality of Life Assessed by LYMQOL","Lymphedema-related quality of life will be assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).",{"measure":27,"description":28,"timeFrame":12},"Change in Upper-Extremity Pain Assessed by Visual Analog Scale","Upper-extremity pain experienced during the previous week will be evaluated using a Visual Analog Scale (VAS).",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"NON_RANDOMIZED","PARALLEL","Participants will be assigned to one of two parallel treatment groups: complete decongestive therapy (CDT) alone or CDT combined with extracorporeal shock wave therapy (ESWT).","TREATMENT",{"masking":36,"maskingDescription":29,"whoMasked":37},"SINGLE",[38],"OUTCOMES_ASSESSOR","Breast cancer-related lymphedema is a chronic condition characterized by impaired lymphatic drainage, accumulation of protein-rich interstitial fluid, chronic inflammation, and progressive tissue fibrosis. Complete decongestive therapy is currently considered the standard treatment for lymphedema. However, treatment response may be insufficient in some patients, and additional physical therapy modalities may be required.\n\nExtracorporeal shock wave therapy is a mechanotherapy modality that generates high-amplitude mechanical acoustic waves. Previous studies suggest that low-energy ESWT may promote tissue regeneration, endothelial neoangiogenesis, modulation of inflammation, reduction of pain, prevention of soft-tissue fibrosis, and lymphangiogenesis.\n\nThe present study aims to investigate whether the addition of ESWT to complete decongestive therapy provides additional clinical benefits compared with complete decongestive therapy alone in patients with breast cancer-related Stage II lymphedema.\n\nUnlike previous studies that have primarily evaluated short-term outcomes, participants in this study will also be assessed at 3 months after completion of treatment. In addition, only patients with a lymphedema duration of less than 4 years and Stage II disease will be included. Ultrasonographic assessment of skin and subcutaneous tissue thickness will also be performed to investigate the potential effects of ESWT on tissue fibrosis.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Complete Decongestive Therapy","ACTIVE_COMPARATOR","Participants in this group will receive Phase I complete decongestive therapy for three weeks. Treatment will consist of manual lymphatic drainage, multilayer short-stretch bandaging, and lymphedema exercises.\n\nComplete decongestive therapy will be administered five sessions per week for a total of 15 sessions.",[46],"Other: Complete Decongestive Therapy",{"label":48,"type":49,"description":50,"interventionNames":51},"Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy","EXPERIMENTAL","Participants in this group will receive Phase I complete decongestive therapy together with extracorporeal shock wave therapy.\n\nComplete decongestive therapy will be administered five sessions per week for three weeks, for a total of 15 sessions.\n\nExtracorporeal shock wave therapy will be administered three sessions per week for three weeks.",[46,52],"Device: Extracorporeal Shock Wave Therapy",[54,59],{"type":6,"name":42,"description":55,"armGroupLabels":56,"otherNames":57},"Complete decongestive therapy will consist of manual lymphatic drainage performed by an experienced physiotherapist according to the Vodder technique for 45-60 minutes, followed by multilayer short-stretch bandaging and lymphedema exercises performed under the supervision of the physiotherapist.\n\nTreatment will be administered five sessions per week for a total of 15 sessions.\n\nArm Cross-Reference:\n\nComplete Decongestive Therapy\n\nComplete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy",[42,48],[58],"CDT",{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"DEVICE","Extracorporeal Shock Wave Therapy","Radial extracorporeal shock wave therapy will be administered using a pressure of 2 bar, a frequency of 4 Hz, and a total of 2,500 shocks per session.\n\nThe shocks will be distributed as follows:\n\nAxillary region: 750 shocks\n\nUpper arm: 500 shocks\n\nCubital region: 250 shocks\n\nForearm: 500 shocks\n\nDorsum of the hand: 500 shocks\n\nESWT will be administered three sessions per week for three weeks.\n\nArm Cross-Reference:\n\nComplete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy",[48],[65],"ESWT",[67],{"name":68,"affiliation":69,"role":70},"sibel ünsal delialioğlu, MD","Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital","PRINCIPAL_INVESTIGATOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":29,"email":76},"şebnem över, MD","CONTACT","05422477954","sebnemfahli@gmail.com",[78],{"facility":69,"status":79,"city":80,"state":29,"zip":29,"country":81,"countryCode":29,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"RECRUITING","Ankara","Turkey (Türkiye)",{"type":83,"coordinates":84},"Point",[85,86],32.85427,39.91987,{"lat":86,"lon":85},[89,91,93],{"name":90,"role":74,"phone":75,"phoneExt":29,"email":76},"ŞEBNEM ÖVER, MD",{"name":73,"role":92,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"name":68,"role":70,"phone":29,"phoneExt":29,"email":29},{"type":70,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Şebnem Fahlioğulları","Physical Medicine and Rehabilitation Resident Physician","100658683","effect-of-eswt-on-breast-cancer-related-lymphedema-100658683",false,"NCT07854262","EFFECT OF ESWT ON BREAST-CANCER RELATED LYMPHEDEMA","EFFECTIVENESS OF EXTRACORPOREAL SHOCK-WAVE THERAPY(ESWT) IN PATIENTS WITH BREAST CANCER-RELATED LYMPHEDEMA","Inclusion Criteria:Female patients with unilateral upper-extremity lymphedema related to breast cancer.\n\nAt least 2 years have elapsed since the diagnosis of breast cancer, cancer treatment has been completed, and cure has been documented during oncology follow-up.\n\nStage II lymphedema according to the International Society of Lymphology classification.\n\nDuration of lymphedema of less than 4 years.\n\nVoluntary participation in the study. -\n\nExclusion Criteria: Poor general health status.\n\nOpen wounds, sensory deficits, or other conditions in the treatment area that may constitute a contraindication to treatment.\n\nActive infection.\n\nPresence of metastasis.\n\nBilateral breast cancer.\n\nBilateral lymphedema.\n\nUse of anticoagulant therapy or presence of a coagulation disorder.\n\nCognitive impairment that may prevent completion of study assessment procedures.\n\nPhysical therapy, including electrotherapy or exercise therapy, ESWT, or regular use of nonsteroidal anti-inflammatory drugs within the previous 6 months.\n\nSystemic inflammatory or autoimmune disorders such as rheumatoid arthritis or systemic lupus erythematosus.\n\n\\-","FEMALE","18 Years",{"count":107,"type":108},48,"ESTIMATED","INTERVENTIONAL",[111],"NA","The aim of this study is to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) combined with complete decongestive therapy (CDT) compared with CDT alone in patients with breast cancer-related lymphedema.\n\nFemale patients with unilateral Stage II upper-extremity lymphedema related to breast cancer will be included. Participants will receive either complete decongestive therapy alone or complete decongestive therapy combined with extracorporeal shock wave therapy.\n\nClinical outcomes will be evaluated before treatment, immediately after treatment, and at 1 and 3 months after treatment. Primary outcomes will include limb circumference difference, volumetric measurements, and ultrasonographic assessment of skin and subcutaneous tissue thickness. Secondary outcomes will include upper-extremity function, quality of life, and pain.",[114],"Breast Cancer Related Lymphedema","2026-09-28",{"date":117,"type":118},"2026-10-02","ACTUAL",{"date":120,"type":118},"2024-11-20",{"date":122,"type":108},"2026-10-14",{"name":5,"class":6},1]