[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589537":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":74,"collaborators":18,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":18,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":18,"enrollmentInfo":86,"targetDuration":18,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":102,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Salamanca","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cryotherapy on Eyebrows + Chemotherapy (Anthracyclines and Taxanes)","EXPERIMENTAL","Cryotherapy is administered via thermally regulated cold eye masks (-10°C ± 2°C) positioned over the supraorbital region, with application commencing 15 minutes pre-chemotherapy and continuing through the infusion period plus 20 minutes post-administration. Chemotherapy includes anthracyclines (doxorubicin\u002Fepirubicin) and\u002For taxanes (paclitaxel\u002Fdocetaxel) per standard protocols.",[13],"Device: cryotherapy for chemotherapy-induced madarosis",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard chemotherapy (no cryotherapy)","NO_INTERVENTION","Patients receive anthracycline\u002Ftaxane-based chemotherapy per institutional protocols without application of cold eye masks or any cryotherapy intervention. All other supportive care measures match the experimental group.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","cryotherapy for chemotherapy-induced madarosis","Application of temperature-controlled cold devices (-4°C to -7°C) to the supraorbital area (up to 3 cm above the eyelid margin), administered 15 minutes before chemotherapy infusion and maintained for 20 minutes post-infusion.",[9],[26],{"name":27,"affiliation":28,"role":29},"Marta González Fernández-Conde","Universidad Salamanca","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Marta González Fernández-Conde, PhD Nursing","CONTACT","661544179","martagfc@usal.es",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Aline Rodrigues Françoso, PhD Nursing","645182581","arodrigues@saludcastillayleon.es",[41,61],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hospital Marqués de Valdecilla","RECRUITING","Santander","Cantabria","39011","Spain","ES",{"type":50,"coordinates":51},"Point",[52,53],-3.80493,43.46589,{"lat":53,"lon":52},[56,57],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":58,"role":33,"phone":59,"phoneExt":18,"email":60},"Patricia Bernardo Heras, RN","691184614","pattberh@gmail.com",{"facility":62,"status":43,"city":63,"state":63,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Hospital Universitario de Salamanca","Salamanca","37007",{"type":50,"coordinates":66},[67,68],-5.66388,40.96882,{"lat":68,"lon":67},[71,72],{"name":27,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":73,"role":33,"phone":38,"phoneExt":18,"email":39},"Aline Rodrigues Françoso",{"type":29,"investigatorFullName":27,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PhD, Nursing Professor Ávila School of Nursing (affiliated to University of Salamanca)","100589537","effect-of-cryotherapy-in-the-prevention-of-madarosis-produced-by-chemotherapy-in-breast-cancer-patients-100589537",false,"NCT06955702","Effect of Cryotherapy in the Prevention of Madarosis Produced by Chemotherapy in Breast Cancer Patients","Effect of Cryotherapy in the Prevention of Alopecia in Eyebrows and Eyelashes in Breast Cancer Patients Treated With Anthracyclines and Taxanes","Inclusion Criteria:\n\n* Female participants aged ≥18 years\n* Newly diagnosed breast cancer (any stage)\n* Scheduled to receive anthracycline- and\u002For taxane-based chemotherapy as first-line systemic treatment\n* No prior history of antineoplastic treatment\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients with recurrent disease who have received prior hormone therapy, chemotherapy, and\u002For immunotherapy\n* Presence of alopecia prior to the initiation of cancer treatment\n* History of cerebral radiotherapy",true,"FEMALE","18 Years",{"count":87,"type":88},120,"ESTIMATED","INTERVENTIONAL",[91],"NA","Chemotherapy-induced alopecia (CIA) significantly compromises body image in breast cancer patients, particularly when involving eyebrow and eyelash loss (madarosis). While scalp cooling devices are routinely employed to prevent scalp alopecia, no standardized interventions exist for madarosis prevention. This quasi-experimental study assesses the efficacy of targeted eyebrow cryotherapy in reducing anthracycline- and taxane-induced madarosis.\n\nThe trial will enroll patients from two tertiary hospitals in Salamanca (intervention arm: cryotherapy) and a control cohort from Santander. Cryotherapy will be administered (-4°C to -7°C) 15 minutes pre-chemotherapy infusion and maintained for 20 minutes post-infusion. Primary outcomes include hair retention quantified through photogrammetric analysis (TIDOP Research Group) at four timepoints: baseline, mid-treatment, chemotherapy completion, and 1-month follow-up. Secondary endpoints evaluate quality of life (QLQ-C30 validated scales) and cryotherapy-related adverse events (CTCAE v5.0 criteria).\n\nThis investigation aims to establish the first evidence-based protocol for madarosis prevention and develop a novel alopecia classification scale, addressing a critical gap in supportive oncology care",[94,95,96,97,98,99,100,101],"Breast Neoplasms","Alopecia","Madarosis","Eyebrow Diseases","Eyelash Diseases","Anthracyclines","Taxoids","Side Effects",[103,96,104,105,106,107,108,109,110,111],"Chemotherapy-induced alopecia","Eyebrow preservation","Taxane-induced alopecia","Anthracycline-induced alopecia","Cryotherapy","Supportive care in oncology","Quality of life","Scalp cooling","Patient-reported outcomes","2025-05-17",{"date":114,"type":115},"2025-05-22","ACTUAL",{"date":117,"type":115},"2023-11-15",{"date":119,"type":88},"2026-08-31",{"name":5,"class":6},2]