Advanced or Metastatic Solid TumourPhase 2SCARLET-ICENCT07474558
SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates
A Phase 2 study testing scalp cooling, photographs via the Belle.AI app and Antibody-Drug Conjugates in people with Advanced or Metastatic Solid Tumour and Antibody-Drug Conjugate, run by Jules Bordet Institute at 3 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced or Metastatic Solid Tumour, Antibody-Drug Conjugate, Alopecia
- What is being tested?
- scalp cooling, photographs via the Belle.AI app and Antibody-Drug Conjugates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesBelgium
- Study dates
- Sep 2026to Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age ≥ 18 years
- ECOG performance status (PS) 0-2
- Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE < 2)
- Participants with histologically or cytologically confirmed advanced or metastatic solid tumour
- Planned initiation of standard of care antibody-drug conjugate (namely, trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan) at any clinically appropriate dose and schedule
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- Life expectancy > 6 months
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Participant is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
Who cannot join
- Known pregnant and/or lactating women.
- 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
- Active haematological malignancy diagnosis
- Known or suspected scalp metastases at screening
- Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy)
- History of cold intolerance syndromes (e.g. cryoglobulinaemia, cold agglutinin disease, or cold urticaria)
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- Active scalp dermatological disease likely to interfere with cooling or assessments (e.g. lupus erythematosus, lichen planus)
- Known hypersensitivity to device cap materials or coolant
- Uncontrolled migraine or chronic headache disorders worsened by cold exposure, in the investigator's judgement
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Evandro de Azambuja Medical oncologist, Study Chair, MD PhD contact
Belgium3 sites
Institut Jules Bordet
Anderlecht, Brussels Capital, 1070
Laura Polastro, MD, laura.polastro@hubruxelles.be
CHU Helora - Hopital de Mons - Site Kennedy
Mons, 7000
Xiaoxiao Wang, MD, 0032 65 41 38 29, xiaoxiao.wang@helora.be
CHU UCL Namur Site Sainte Elisabeth
Namur
Donatienne Taylor, MD, donatienne.taylor@chuuclnamur.uclouvain.be
About this study
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.
- Being tested
- scalp cooling, photographs via the Belle.AI app, Antibody-Drug Conjugates
- Keywords
- ADC, Antibody-drug conjugates, advanced or metastatic solid tumour, scalp cooling, hair loss, alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scalp coolingDevice
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
photographs via the Belle.AI appOther
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
Antibody-Drug ConjugatesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Scalp cooling Receives: Device: scalp cooling; Other: photographs via the Belle.AI app; Drug: Antibody-Drug Conjugates |
| Control | Other | Observation Receives: Other: photographs via the Belle.AI app; Drug: Antibody-Drug Conjugates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. The 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). The 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. Scalp 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.
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- BelleTorus Corporation, Gilead Sciences, Paxman
- Responsible party
- Sponsor
- Investigators
- Evandro de Azambuja, MD PhD, Study chair, Medical oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474558
- Sponsor's protocol ID
- IJB-SCARLET-ICE-2025
- Acronym
- SCARLET-ICE
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates
- ClinicalTrials.gov ID
- NCT07474558
- Acronym / sponsor ID
- SCARLET-ICE / IJB-SCARLET-ICE-2025
- Keywords
- ADC, Antibody-drug conjugates, advanced or metastatic solid tumour, scalp cooling, hair loss, alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- BelleTorus Corporation, Gilead Sciences, Paxman
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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. The 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). The 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. Scalp 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: scalp cooling, Other: photographs via the Belle.AI app, Drug: Antibody-Drug ConjugatesScalp cooling |
| Control | Other | Other: photographs via the Belle.AI app, Drug: Antibody-Drug ConjugatesObservation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age ≥ 18 years
- ECOG performance status (PS) 0-2
- Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE < 2)
- Participants with histologically or cytologically confirmed advanced or metastatic solid tumour
Key exclusion criteria (10 listed)
- Known pregnant and/or lactating women.
- 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
- Active haematological malignancy diagnosis
- Known or suspected scalp metastases at screening
- Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scalp coolingscalp 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 | Device | Experimental |
| photographs via the Belle.AI appartificial 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 | Other | Control, Experimental |
| Antibody-Drug Conjugatesstudy 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. | Drug | Control, Experimental |
Primary outcome
percentage of participants with hair loss
Time frame: 3 months
defined as the Severity of Alopecia Tool (SALT) score greater than zero The SALT score is calculated as follows: 1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital. 2. 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.). 3. 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.
5 secondary outcomes
degree of hair loss
Time frame: 3 months
Change from baseline in quality of life
Time frame: at each cycle of treatment + 28 days following end of treatment
Change from baseline in quality of life
Time frame: at each cycle of treatment + 28 days after the end of treatment
Frequency, and severity of adverse events related to scalp cooling
Time frame: 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
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evandro de Azambuja Medical oncologist, Study Chair, MD PhD contact
Evandro de Azambuja, MD PhD study chair
Medical oncologist
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing scalp cooling, photographs via the Belle.AI app and Antibody-Drug Conjugates in people with Advanced or Metastatic Solid Tumour and Antibody-Drug Conjugate, run by Jules Bordet Institute at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evandro de Azambuja Medical oncologist, Study Chair, MD PhD (+32 2 541 7244, evandro.deazambuja@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of participants with hair loss (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.