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Cool cap may save hair during powerful cancer treatment

NCT ID NCT07474558

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU Helora - Hopital de Mons - Site Kennedy

    Mons, 7000, Belgium

  • CHU UCL Namur Site Sainte Elisabeth

    Namur, Belgium

  • Institut Jules Bordet

    Anderlecht, Brussels Capital, 1070, Belgium

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