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

Free University of Brussels (ULB)

Status and phase: Begins enrollment in 4 months; Phase 2

Conditions: Advanced or Metastatic Solid Tumour; Alopecia; Antibody-Drug Conjugate

Treatments: Other: photographs via the Belle.AI app; Drug: Antibody-Drug Conjugates; Device: scalp cooling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07474558

IJB-SCARLET-ICE-2025

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Experimental

Experimental group

Description:

Scalp cooling

Treatment:

Device: scalp cooling

Drug: Antibody-Drug Conjugates

Other: photographs via the Belle.AI app

Control

Other group

Description:

Observation

Treatment:

Drug: Antibody-Drug Conjugates

Other: photographs via the Belle.AI app