SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates (SCARLET-ICE)

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.

The 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.

Researchers 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alopecia; Advanced or Metastatic Solid Tumour; Antibody-Drug Conjugate
• Intervention / Treatment: Device: scalp cooling; Other: photographs via the Belle.AI app; Drug: Antibody-Drug Conjugates

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Evandro de Azambuja Medical oncologist, Study Chair, MD PhD; Phone Number: +32 2 541 7244; Email: evandro.deazambuja@hubruxelles.be

Study Locations

• Belgium
  • Namur, Belgium
    • CHU UCL Namur Site Sainte Elisabeth
    • Contact: Donatienne Taylor, MD; Email: donatienne.taylor@chuuclnamur.uclouvain.be
  • Brussels Capital
    • Anderlecht, Brussels Capital, Belgium, 1070
      • Institut Jules Bordet
      • Contact: Laura Polastro, MD; Email: laura.polastro@hubruxelles.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female
2. Age ≥ 18 years
3. ECOG performance status (PS) 0-2
4. Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE < 2)
5. Participants with histologically or cytologically confirmed advanced or metastatic solid tumour
6. Planned initiation of standard of care antibody-drug conjugate (namely, trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan) at any clinically appropriate dose and schedule
7. Life expectancy > 6 months
8. Signed Informed Consent form (ICF) obtained prior to any study related procedure.
9. Participant is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations

Exclusion Criteria:

1. Known pregnant and/or lactating women.
2. 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
3. Active haematological malignancy diagnosis
4. Known or suspected scalp metastases at screening
5. Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy)
6. History of cold intolerance syndromes (e.g. cryoglobulinaemia, cold agglutinin disease, or cold urticaria)
7. Active scalp dermatological disease likely to interfere with cooling or assessments (e.g. lupus erythematosus, lichen planus)
8. Known hypersensitivity to device cap materials or coolant
9. Uncontrolled migraine or chronic headache disorders worsened by cold exposure, in the investigator's judgement
10. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Scalp cooling	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; Other: 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; 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.
Other: Control; Observation	Other: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of participants with hair loss	defined as the Severity of Alopecia Tool (SALT) score greater than zero The SALT score is calculated as follows: Divide the scalp into four equal quadrants: frontal, right, left, and occipital.; 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.).; Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A 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. assessed by blinded central dermatological review.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of hair loss	percentage increase in SALT score relative to baseline The SALT score is calculated as follows: Divide the scalp into four equal quadrants: frontal, right, left, and occipital.; 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.).; Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A 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. assessed by blinded central dermatological review.	3 months
Change from baseline in quality of life	Body Image Scale (BIS) questionnaire The BIS questionnaire consists of 10 items; each rated on a four-point scale from "not at all (=0) " to "very much (=3)." Items include : Feeling 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 High scores indicate higher body image.	at each cycle of treatment + 28 days following end of treatment
Change from baseline in quality of life	Chemotherapy-Induced Alopecia Distress Scale (CADS) The 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. Each 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.	at each cycle of treatment + 28 days after the end of treatment
Frequency, and severity of adverse events related to scalp cooling	National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE).	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
compare scalp hair loss assessment across three methods	concordance and absolute differences in SALT scores between; AI-driven analysis leveraging Belle-AI to generate precise SALT score evaluations; Local investigator assessment; Central dermatologist assessment The SALT score is calculated as follows: Divide the scalp into four equal quadrants: frontal, right, left, and occipital.; 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.).; Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A 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. assessed by blinded central dermatological review.	3 months

Collaborators and Investigators

• Sponsor: Jules Bordet Institute
• Collaborators: Gilead Sciences; Paxman; BelleTorus Corporation
• Investigators: Study Chair: Evandro de Azambuja, MD PhD, Medical Oncologist

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ADC; alopecia; hair loss; scalp cooling; Antibody-drug conjugates; advanced or metastatic solid tumour
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Immunologic Factors; Physiological Effects of Drugs; Amino Acids, Peptides, and Proteins; Proteins; Pharmacologic Actions; Chemical Actions and Uses; Antibodies; Immunoglobulins; Blood Proteins; Serum Globulins; Globulins; Immunoconjugates
• Other Study ID Numbers: IJB-SCARLET-ICE-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No