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NCT Number: NCT07474558

SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates

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.

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Key information

Conditions

Advanced or Metastatic Solid Tumour Alopecia Antibody-Drug Conjugate Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Institut Jules Bordet, Anderlecht, Brussels Capital, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

scalp cooling

Device

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 app

Other

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 Conjugates

Drug

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.

Primary outcomes

  1. 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:

    • 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.

Secondary outcomes

  1. degree of hair loss

    Time frame: 3 months

    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.

  2. Change from baseline in quality of life

    Time frame: at each cycle of treatment + 28 days following end of treatment

    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.

  3. Change from baseline in quality of life

    Time frame: at each cycle of treatment + 28 days after the end of treatment

    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.

  4. 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

    National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE).

  5. compare scalp hair loss assessment across three methods

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Evandro de Azambuja Medical oncologist, Study Chair, MD PhD

CONTACT

[email protected]

+32 2 541 7244

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Collaborators

  • BelleTorus Corporation
  • Gilead Sciences
  • Paxman

Registry information

Acronym: SCARLET-ICE

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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