SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates (NCT07474558) | Clinical Trial Compass
Not Yet RecruitingPhase 2
SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates
Belgium102 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female
✓. Age ≥ 18 years
✓. ECOG performance status (PS) 0-2
✓. Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE \< 2)
✓. Participants with histologically or cytologically confirmed advanced or metastatic solid tumour
✓. Planned initiation of standard of care antibody-drug conjugate (namely, trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan) at any clinically appropriate dose and schedule
✓. Life expectancy \> 6 months
✓. Signed Informed Consent form (ICF) obtained prior to any study related procedure.
Exclusion criteria
✕. Known pregnant and/or lactating women.
✕. 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
What they're measuring
1
percentage of participants with hair loss
Timeframe: 3 months
Trial details
NCT IDNCT07474558
SponsorJules Bordet Institute
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2030-01
Contact for this trial
Evandro de Azambuja Medical oncologist, Study Chair, MD PhD