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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
scalp cooling
Devicescalp cooling at -10°C for each cycle of ADC, subjects will ubdergo scalp cooling : 30 minutes prior ADC treatment, during ADC treatment and 90 minutes following ADC treatment
photographs via the Belle.AI app
Other interventionartificial intelligence-based software tool designed for standardised photographic documentation and automated assessment of alopecia severity using the Severity of Alopecia Tool (SALT) scale generated AI Score will be blinded for investigator and patient outcome does not impact treatment of the subject
Antibody-Drug Conjugates
Drugstudy will randomize female participants receiving one of the following ADCs as part of their standard-of-care treatment: sacituzumab-govitecan, trastuzumab-deruxtecan, or datopotamab-deruxtecan.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 3 interventions
Group B: ControlOther 2 interventions
Trial outcomes
Primary outcomes
1
percentage of participants with hair loss
defined as the Severity of Alopecia Tool (SALT) score greater than zero The SALT score is calculated as follows: 1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital. 2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.). 3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss. assessed by blinded central dermatological review.
Time frame
3 monthsSecondary outcomes
1
degree of hair loss
percentage increase in SALT score relative to baseline The SALT score is calculated as follows: 1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital. 2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.). 3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss. assessed by blinded central dermatological review.
Time frame
3 months2
Change from baseline in quality of life
Body Image Scale (BIS) questionnaire The BIS questionnaire consists of 10 items; each rated on a four-point scale from "not at all (=0) " to "very much (=3)." Items include : Feeling self-conscious about appearance Feeling less physically attractive due to disease or treatment Dissatisfaction with appearance when dressed Feeling less feminine/masculine Difficulty looking at oneself naked Feeling less sexually attractive Avoiding people because of appearance Feeling the body is less whole General dissatisfaction with the body High scores indicate higher body image.
Time frame
at each cycle of treatment + 28 days following end of treatment3
Change from baseline in quality of life
Chemotherapy-Induced Alopecia Distress Scale (CADS) The CADS is a validated psychometric scale used to assess the distress experienced by patients as a result of chemotherapy-induced alopecia. It consists of 25 items divided into five domains: physical, emotional, activities, relationships, and treatment. Each item is rated by the patient on a four-point Likert scale, ranging from "not at all" (1) to "very much" (4). Higher scores indicate greater distress related to body image.
Time frame
at each cycle of treatment + 28 days after the end of treatment4
Frequency, and severity of adverse events related to scalp cooling
National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE).
Time frame
all along study : from first day of treatment until 6 months follow up after the last administration of study treatment or before starting any new anticancer treatment, whichever comes firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jules Bordet Institute
Lead sponsor
BelleTorus Corporation
Collaborator
Gilead Sciences
Collaborator
Paxman
Collaborator
Source ClinicalTrials.gov
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