A Phase 2 interventional study of scalp cooling and photographs via the Belle.AI app in Advanced or Metastatic Solid Tumour, Antibody-Drug Conjugate and Alopecia, sponsored by Jules Bordet Institute. Not yet recruiting at 3 sites in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Jules Bordet Institute · Phase 2, Interventional, and Other
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.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's planned enrollment of 102 is above the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Jules Bordet Institute is the lead sponsor of 106 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Scalp cooling
Device: scalp cooling · Other: photographs via the Belle.AI app · Drug: Antibody-Drug Conjugates
Observation
Other: photographs via the Belle.AI app · Drug: Antibody-Drug Conjugates
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
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.
This study also gives Trastuzumab deruxtecan, Datopotamab deruxtecan, Sacituzumab govitecan. No intervention listed here names it: that was found by reading the record.
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 months
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 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.
Time frame: 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.
Time frame: 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).
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 first
compare scalp hair loss assessment across three methods
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.
Time frame: 3 months
Start is estimated for Sep 2026; primary completion for Jan 2030, 40 months later.
Of 41 phase 2 interventional studies under Alopecia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's planned 40 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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