SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJules Bordet Institute
About this trial
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
Qualifiers
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)
Disqualifiers
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
Active haematological malignancy diagnosis
Known or suspected scalp metastases at screening
Trial design
Treatments tested in this trial
- scalp cooling
- photographs via the Belle.AI app
- Antibody-Drug Conjugates
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jules Bordet Institute
Lead sponsor
BelleTorus Corporation
Collaborator
Gilead Sciences
Collaborator
Paxman
Collaborator
Source ClinicalTrials.gov