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.

NCT Number	NCT07474558
Lead Sponsor	Jules Bordet Institute Collaborators: BelleTorus Corporation, Gilead Sciences, Paxman
Conditions	Advanced or Metastatic Solid Tumour, Antibody-Drug Conjugate, Alopecia
Enrollment	102 participants
Start Date	2026-09
Primary Completion	2030-01 (estimated)
Study Completion	2031-09 (estimated)
Updated on ClinicalTrials.gov	2026-03-16