SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates

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