SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates
Trial ID: NCT07474558
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE2
Start date: 2026-09
Completion date: 2031-09
Sponsor: Jules Bordet Institute
Collaborators: BelleTorus Corporation; Gilead Sciences; Paxman
Conditions: Advanced or Metastatic Solid Tumour; Antibody-Drug Conjugate; Alopecia
Interventions: scalp cooling; photographs via the Belle.AI app; Antibody-Drug Conjugates
Locations: Institut Jules Bordet; CHU UCL Namur Site Sainte Elisabeth
Countries: Belgium; Belgium
Enrollment: 102
Age range: 18 Years - None
Sex: FEMALE

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.

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.

Eligibility criteria:
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

Outcomes:
percentage of participants with hair loss