drugset / Trial / NCT07474558

SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates

NCT07474558

RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2026-09
Primary completion
2030-01
Completion
2031-09

Drugs

EvaluationDrugModalityDoseRoute
Background Datopotamab deruxtecan Monoclonal antibody
Background Sacituzumab Govitecan Monoclonal antibody
Background Trastuzumab deruxtecan Monoclonal antibody