Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:25 AM
Study NCT ID:
NCT07474558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018796', 'term': 'Immunoconjugates'}], 'ancestors': [{'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Dermatologists Committee who will centrally assess alopecia (providing SALT score)'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label, randomized, controlled, multi-centric clinical investigation designed to evaluate the efficacy and safety of scalp cooling in preventing CIA in participants with advanced or metastatic solid tumours treated with "new" ADC.\n\nThe study will compare scalp cooling versus observation (no cooling) in a 1:1 randomisation, stratified by type of ADC used (T-DXd, SG or Dato-DXd) and previous alopecia (yes vs. no).\n\nThe 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.\n\nScalp cooling, with the coolant at -10ºC, will be applied prior to, during, and after each ADC infusion using the Paxman Scalp Cooling System. The intervention will continue until one of the following, whichever occurs first: unacceptable scalp cooling-related toxicity, discontinuation of the ADC for any reason, or a maximum of six months of treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2031-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of participants with hair loss', 'timeFrame': '3 months', 'description': 'defined as the Severity of Alopecia Tool (SALT) score greater than zero\n\nThe SALT score is calculated as follows:\n\n1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital.\n2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.).\n3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4.\n\nA SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss.\n\nassessed by blinded central dermatological review.'}], 'secondaryOutcomes': [{'measure': 'degree of hair loss', 'timeFrame': '3 months', 'description': 'percentage increase in SALT score relative to baseline\n\nThe SALT score is calculated as follows:\n\n1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital.\n2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.).\n3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4.\n\nA SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss.\n\nassessed by blinded central dermatological review.'}, {'measure': 'Change from baseline in quality of life', 'timeFrame': 'at each cycle of treatment + 28 days following end of treatment', 'description': 'Body Image Scale (BIS) questionnaire\n\nThe BIS questionnaire consists of 10 items; each rated on a four-point scale from "not at all (=0) " to "very much (=3)."\n\nItems include :\n\nFeeling self-conscious about appearance Feeling less physically attractive due to disease or treatment Dissatisfaction with appearance when dressed Feeling less feminine/masculine Difficulty looking at oneself naked Feeling less sexually attractive Avoiding people because of appearance Feeling the body is less whole General dissatisfaction with the body\n\nHigh scores indicate higher body image.'}, {'measure': 'Change from baseline in quality of life', 'timeFrame': 'at each cycle of treatment + 28 days after the end of treatment', 'description': 'Chemotherapy-Induced Alopecia Distress Scale (CADS)\n\nThe CADS is a validated psychometric scale used to assess the distress experienced by patients as a result of chemotherapy-induced alopecia. It consists of 25 items divided into five domains: physical, emotional, activities, relationships, and treatment.\n\nEach item is rated by the patient on a four-point Likert scale, ranging from "not at all" (1) to "very much" (4). Higher scores indicate greater distress related to body image.'}, {'measure': 'Frequency, and severity of adverse events related to scalp cooling', 'timeFrame': 'all along study : from first day of treatment until 6 months follow up after the last administration of study treatment or before starting any new anticancer treatment, whichever comes first', 'description': 'National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE).'}, {'measure': 'compare scalp hair loss assessment across three methods', 'timeFrame': '3 months', 'description': 'concordance and absolute differences in SALT scores between\n\n* AI-driven analysis leveraging Belle-AI to generate precise SALT score evaluations\n* Local investigator assessment\n* Central dermatologist assessment\n\nThe SALT score is calculated as follows:\n\n1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital.\n2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.).\n3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4.\n\nA SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss.\n\nassessed by blinded central dermatological review.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADC', 'Antibody-drug conjugates', 'advanced or metastatic solid tumour', 'scalp cooling', 'hair loss', 'alopecia'], 'conditions': ['Advanced or Metastatic Solid Tumour', 'Antibody-Drug Conjugate', 'Alopecia']}, 'descriptionModule': {'briefSummary': '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/metastatic 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 \\< 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/or 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"}, 'identificationModule': {'nctId': 'NCT07474558', 'acronym': 'SCARLET-ICE', 'briefTitle': 'SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': 'SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates', 'orgStudyIdInfo': {'id': 'IJB-SCARLET-ICE-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Scalp cooling', 'interventionNames': ['Device: scalp cooling', 'Other: photographs via the Belle.AI app', 'Drug: Antibody-Drug Conjugates']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Observation', 'interventionNames': ['Other: photographs via the Belle.AI app', 'Drug: Antibody-Drug Conjugates']}], 'interventions': [{'name': 'scalp cooling', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['Experimental']}, {'name': 'photographs via the Belle.AI app', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Control', 'Experimental']}, {'name': 'Antibody-Drug Conjugates', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Anderlecht', 'state': 'Brussels Capital', 'country': 'Belgium', 'contacts': [{'name': 'Laura Polastro, MD', 'role': 'CONTACT', 'email': 'laura.polastro@hubruxelles.be'}], 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'city': 'Namur', 'country': 'Belgium', 'contacts': [{'name': 'Donatienne Taylor, MD', 'role': 'CONTACT', 'email': 'donatienne.taylor@chuuclnamur.uclouvain.be'}], 'facility': 'CHU UCL Namur Site Sainte Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}], 'centralContacts': [{'name': 'Evandro de Azambuja Medical oncologist, Study Chair, MD PhD', 'role': 'CONTACT', 'email': 'evandro.deazambuja@hubruxelles.be', 'phone': '+32 2 541 7244'}], 'overallOfficials': [{'name': 'Evandro de Azambuja, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical oncologist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'BelleTorus Corporation', 'class': 'INDUSTRY'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'Paxman', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}