Cool cap may save hair during powerful cancer treatment
NCT ID NCT07474558
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This study tests if a special cooling cap can reduce hair loss in people with advanced solid tumors who are receiving a type of chemotherapy called antibody-drug conjugates (ADCs). About 102 women will be split into two groups: one gets the cooling cap during treatment, the other does not. The goal is to see if the cap helps keep more hair, as measured by a standard hair-loss scale.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 102 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Helora - Hopital de Mons - Site Kennedy
Mons, 7000, Belgium
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CHU UCL Namur Site Sainte Elisabeth
Namur, Belgium
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Institut Jules Bordet
Anderlecht, Brussels Capital, 1070, Belgium
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Other studies related to the condition(s) this trial covers.
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