Advanced or Metastatic Solid Tumour, Alopecia, Antibody-Drug Conjugate
Conditions
Keywords
ADC, Antibody-drug conjugates, advanced or metastatic solid tumour, scalp cooling, hair loss, alopecia
Brief 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.
Interventions
DEVICEscalp cooling
scalp 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
OTHERphotographs via the Belle.AI app
artificial 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
study 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.
Sponsors
Jules Bordet Institute
BelleTorus Corporation
Gilead Sciences
Paxman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Dermatologists Committee who will centrally assess alopecia (providing SALT score)
Intervention model description
Open-label, randomized, controlled, multi-centric clinical investigation designed to evaluate the efficacy and safety of scalp cooling in preventing CIA in participants with advanced or metastatic solid tumours treated with "new" ADC. The study will compare scalp cooling versus observation (no cooling) in a 1:1 randomisation, stratified by type of ADC used (T-DXd, SG or Dato-DXd) and previous alopecia (yes vs. no). The study 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. Scalp cooling, with the coolant at -10ºC, will be applied prior to, during, and after each ADC infusion using the Paxman Scalp Cooling System. The intervention will continue until one of the following, whichever occurs first: unacceptable scalp cooling-related toxicity, discontinuation of the ADC for any reason, or a maximum of six months of treatment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female 2. Age ≥ 18 years 3. ECOG performance status (PS) 0-2 4. Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE \< 2) 5. Participants with histologically or cytologically confirmed advanced or metastatic solid tumour 6. Planned initiation of standard of care antibody-drug conjugate (namely, trastuzumab-deruxtecan, sacituzumab-govitecan, or datopotamab-deruxtecan) at any clinically appropriate dose and schedule 7. Life expectancy \> 6 months 8. Signed Informed Consent form (ICF) obtained prior to any study related procedure. 9. Participant is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
Exclusion criteria
1. Known pregnant and/or lactating women. 2. 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 3. Active haematological malignancy diagnosis 4. Known or suspected scalp metastases at screening 5. Planned concurrent alopecia-inducing therapy during ADC treatment (e.g. whole-brain radiotherapy or cytotoxic chemotherapy) 6. History of cold intolerance syndromes (e.g. cryoglobulinaemia, cold agglutinin disease, or cold urticaria) 7. Active scalp dermatological disease likely to interfere with cooling or assessments (e.g. lupus erythematosus, lichen planus) 8. Known hypersensitivity to device cap materials or coolant 9. Uncontrolled migraine or chronic headache disorders worsened by cold exposure, in the investigator's judgement 10. Participants who have already started treatment with an ADC prior to randomisation will be excluded, as scalp cooling must begin with the first ADC infusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of participants with hair loss | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| degree of hair loss | 3 months | 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. |
| Change from baseline in quality of life | at each cycle of treatment + 28 days following end of treatment | 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. |
| Frequency, and severity of adverse events related to scalp cooling | 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 first | National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE). |
| compare scalp hair loss assessment across three methods | 3 months | concordance and absolute differences in SALT scores between * AI-driven analysis leveraging Belle-AI to generate precise SALT score evaluations * Local investigator assessment * Central dermatologist assessment 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. |
Countries
Belgium
Contacts
CONTACTEvandro de Azambuja Medical oncologist, Study Chair, MD PhD
STUDY_CHAIREvandro de Azambuja, MD PhD
Medical oncologist
Outcome results
None listed