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Cool cap may save hair during breast cancer chemo

NCT ID NCT04986579

Symptom relief Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether a special cooling cap can reduce hair loss in people with metastatic breast cancer who are receiving certain chemotherapy drugs. About 120 participants will either use the Paxman Scalp Cooling System or not, and researchers will compare hair loss rates and quality of life. The goal is to see if this simple device can ease a common and distressing side effect of treatment.

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 120 people

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

Started

Oct 2021

Expected to finish

Jun 2030

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

Anyone

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: * Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2 * Participant is ≥ 18 years old. * Hair present at baseline. * One of the following full dose chemotherapy regimens must be planned for at least 4 cycles: * Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle * Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks * Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle * The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group. Exclusion Criteria: * Known hematological malignancies (i.e. leukemia or lymphoma) * Known scalp metastases. * Baseline alopecia (defined CTCAE 5.0 grade \> 0, see Appendix B) * Subjects with cold agglutinin disease or cold urticaria. * Subjects who are scheduled for bone marrow ablation chemotherapy. * Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, the subject may go on study at the discretion of the Principal Investigator. * Subjects who have lichen planus or lupus. * Participants who are receiving any additional anti-cancer agents

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm chemotherapy-induced alopecia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy-induced alopecia Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 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

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

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