[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476518":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":67,"collaborators":20,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":20,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":20,"enrollmentInfo":78,"targetDuration":20,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Cooler Heads Care Inc.","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All patients will use AMMA","EXPERIMENTAL","Device: AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.",[13],"Device: AMMA Portalbe Scalp Cooling System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","AMMA Portalbe Scalp Cooling System","AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Kate Dilligan","Cooler Heads Inc.","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Chris Schultz, BS","CONTACT","9715067552","cschultz@ecr-inc.com",[33,52],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University of Arizona","RECRUITING","Tucson","Arizona","245024","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-110.92648,32.22174,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":20,"email":51},"Sima Ehsani, MD","520-621-2449","simaehsani@arizona.edu",{"facility":53,"status":35,"city":54,"state":55,"zip":56,"country":39,"countryCode":40,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Carle Health","Urbana","Illinois","61801",{"type":42,"coordinates":58},[59,60],-88.20727,40.11059,{"lat":60,"lon":59},[63],{"name":64,"role":29,"phone":65,"phoneExt":20,"email":66},"Maria Perdekamp, MD","217-300-5700","Maria.Grosse-Perdekamp@carle.com",{"type":68,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100476518","study-to-assess-the-ability-of-the-portable-scalp-cooling-system-pscs-to-prevent-hair-loss-100476518",false,"NCT05484973","Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss","A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.","Inclusion Criteria:\n\n1. Female patients ≥ 21 years of age\n2. Documented diagnosis of breast cancer, stage I, II, or III\n3. A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent\n4. Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin Note: Targeted and\u002For hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the AMMA PSCS will not be used during the post-CT targeted and\u002For hormonal therapy period\n5. Plan to complete the current CT regimen within six months\n6. At least two years out from the last CT causing hair loss with complete recovery of hair\n7. Karnofsky17 performance status 80% or greater\n8. Willing and able to sign informed consent for this study\n9. Willing and able to complete all required study procedures\n\nExclusion Criteria:\n\n1. Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale\n2. Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others\n3. A history of whole brain radiation\n4. Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (AC\u002FT, EC\u002FT, TAC, etc.)\n5. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted\n6. Current and\u002For prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique\n7. A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up\n8. History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens\n9. History of and\u002For current exposure to other agents, drugs, device, or procedure that may cause hair loss\n10. Cold sensitivity\n11. Intercurrent life-threatening malignancy\n12. Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism\n13. History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia\n14. Concurrent hematologic malignancy\n15. Participation in any other clinical investigation\n16. Concurrent treatment with any investigational agent\n17. Any reason the investigator does not believe the patient is a good candidate for the study","FEMALE","21 Years",{"count":79,"type":80},99,"ESTIMATED","INTERVENTIONAL",[83],"NA","The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.",[86,87,88,89],"Alopecia","Chemotherapy-induced Alopecia","Hair Loss","Breast Cancer","2025-04-03",{"date":92,"type":93},"2025-04-06","ACTUAL",{"date":95,"type":93},"2024-11-08",{"date":97,"type":80},"2026-09-30",{"name":5,"class":6},2]