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| Name | Class |
|---|---|
| BelleTorus Corporation | INDUSTRY |
| Gilead Sciences | INDUSTRY |
| Paxman | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Scalp cooling |
|
| Control | Other | Observation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scalp cooling | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| degree of hair loss | percentage increase in SALT score relative to baseline The SALT score is calculated as follows:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evandro de Azambuja Medical oncologist, Study Chair, MD PhD | Contact | +32 2 541 7244 | evandro.deazambuja@hubruxelles.be |
| Name | Affiliation | Role |
|---|---|---|
| Evandro de Azambuja, MD PhD | Medical oncologist | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Anderlecht | Brussels Capital | 1070 | Belgium |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
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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 -10ÂșC, 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.
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Dermatologists Committee who will centrally assess alopecia (providing SALT score)
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| photographs via the Belle.AI app | Other | 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 |
|
| Antibody-Drug Conjugates | Drug | 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. |
|
| 3 months |
| 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. | at each cycle of treatment + 28 days following end of treatment |
| 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. | at each cycle of treatment + 28 days after the end of treatment |
| 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). | 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 |
| compare scalp hair loss assessment across three methods | concordance and absolute differences in SALT scores between
The SALT score is calculated as follows:
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. | 3 months |
| CHU UCL Namur Site Sainte Elisabeth | Namur | Belgium |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |