[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629429":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":77,"collaborators":79,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":26,"enrollmentInfo":97,"targetDuration":26,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":114,"whyStopped":26,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Jules Bordet Institute","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Scalp cooling",[13,14,15],"Device: scalp cooling","Other: photographs via the Belle.AI app","Drug: Antibody-Drug Conjugates",{"label":17,"type":6,"description":18,"interventionNames":19},"Control","Observation",[14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","scalp cooling","scalp cooling at -10°C for each cycle of ADC, subjects will ubdergo scalp cooling : 30 minutes prior ADC treatment, during ADC treatment and 90 minutes following ADC treatment",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"photographs via the Belle.AI app","artificial intelligence-based software tool designed for standardised photographic documentation and automated assessment of alopecia severity using the Severity of Alopecia Tool (SALT) scale generated AI Score will be blinded for investigator and patient outcome does not impact treatment of the subject",[17,9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"DRUG","Antibody-Drug Conjugates","study will randomize female participants receiving one of the following ADCs as part of their standard-of-care treatment: sacituzumab-govitecan, trastuzumab-deruxtecan, or datopotamab-deruxtecan.",[17,9],[37],{"name":38,"affiliation":39,"role":40},"Evandro de Azambuja, MD PhD","Medical oncologist","STUDY_CHAIR",[42],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},"Evandro de Azambuja Medical oncologist, Study Chair, MD PhD","CONTACT","+32 2 541 7244","evandro.deazambuja@hubruxelles.be",[48,65],{"facility":49,"status":26,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Institut Jules Bordet","Anderlecht","Brussels Capital","1070","Belgium","BE",{"type":56,"coordinates":57},"Point",[58,59],4.31454,50.83619,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":26,"phoneExt":26,"email":64},"Laura Polastro, MD","laura.polastro@hubruxelles.be",{"facility":66,"status":26,"city":67,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"CHU UCL Namur Site Sainte Elisabeth","Namur",{"type":56,"coordinates":69},[70,71],4.86746,50.4669,{"lat":71,"lon":70},[74],{"name":75,"role":44,"phone":26,"phoneExt":26,"email":76},"Donatienne Taylor, MD","donatienne.taylor@chuuclnamur.uclouvain.be",{"type":78,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[80,83,85],{"name":81,"class":82},"BelleTorus Corporation","INDUSTRY",{"name":84,"class":82},"Gilead Sciences",{"name":86,"class":87},"Paxman","UNKNOWN","100629429","phase-2-scalp-cooling-for-preventing-alopecia-with-new-antibody-drug-conjugates-100629429",false,"NCT07474558","SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates","SCARLET-ICE","Inclusion Criteria:\n\n1. Female\n2. Age ≥ 18 years\n3. ECOG performance status (PS) 0-2\n4. Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE \\\u003C 2)\n5. Participants with histologically or cytologically confirmed advanced or metastatic solid tumour\n6. Planned initiation of standard of care antibody-drug conjugate (namely, trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan) at any clinically appropriate dose and schedule\n7. Life expectancy \\> 6 months\n8. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n9. Participant is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations\n\nExclusion Criteria:\n\n1. Known pregnant and\u002For lactating women.\n2. Participant with a known significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study\n3. Active haematological malignancy diagnosis\n4. Known or suspected scalp metastases at screening\n5. Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy)\n6. History of cold intolerance syndromes (e.g. cryoglobulinaemia, cold agglutinin disease, or cold urticaria)\n7. Active scalp dermatological disease likely to interfere with cooling or assessments (e.g. lupus erythematosus, lichen planus)\n8. Known hypersensitivity to device cap materials or coolant\n9. Uncontrolled migraine or chronic headache disorders worsened by cold exposure, in the investigator's judgement\n10. Participants who have already started treatment with an ADC prior to randomisation will be excluded, as scalp cooling must begin with the first ADC infusion","FEMALE","18 Years",{"count":98,"type":99},102,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","The goal of this interventional study is to determine if scalp cooling (by the Paxman Scalp Cooling System) reduces the extent and severity of alopecia in participants with advanced solid tumours receiving ADC.\n\nThe main question it aims to evaluate the efficacy of scalp cooling in reducing chemotherapy-induced alopecia in participants with advanced\u002Fmetastatic solid tumours receiving antibody-drug conjugates (trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan), as assessed by blinded central dermatological review.\n\nResearchers will compare the experimental arm (ADC treatment + scalp cooling) with the control arm (ADC only). Scalp cooling will be done each day of ADC treatment : before, during and post-infusions of their ADC treatment.",[105,106,107],"Advanced or Metastatic Solid Tumour","Antibody-Drug Conjugate","Alopecia",[109,110,111,23,112,113],"ADC","Antibody-drug conjugates","advanced or metastatic solid tumour","hair loss","alopecia","NOT_YET_RECRUITING","2026-03-11",{"date":117,"type":118},"2026-03-16","ACTUAL",{"date":120,"type":99},"2026-09",{"date":122,"type":99},"2031-09",{"name":5,"class":6},2]