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Cool cap could keep hair on during chemo

NCT ID NCT06215469

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a portable scalp cooling system called Amma to see if it can prevent hair loss in women receiving chemotherapy for early-stage breast cancer. Forty women with stage I-III breast cancer will use the cooling cap during their chemo sessions. The goal is to see if most women keep at least half their hair, with fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amma Portable Scalp Cooling System (a cooling cap device)
What this could lead to
If it works, this device could help women keep most of their hair during chemotherapy, reducing emotional distress.
What could go wrong
This is a small, post-market study with only 40 participants, so results may not apply to everyone. The device may cause discomfort or fail to prevent hair loss for some.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

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

Started

May 2024

Expected to finish

Dec 2029

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

21 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: 1. Participants must have histologically or cytologically confirmed breast cancer, stage I, II, or III. 2. A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent. 3. Plan to complete the current CT regimen within six months. 4. Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin. Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the Amma PSCS will not be used during the post-CT targeted and/or hormonal therapy period. 5. At least two years out from the last CT causing hair loss with complete recovery of hair. 6. Age \>=21 years 7. Eastern Cooperative Oncology Group (ECOG) performance status of \<=1. 8. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale. 2. Autoimmune disease affecting hair, e.g., alopecia areata, systemic lupus with associated hair loss, others. 3. A history of whole brain radiation. 4. Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (doxorubicin and cyclophosphamide followed by paclitaxel (AC/T), epirubicin, cyclophosphamide, and docetaxel or paclitaxel (EC/T), docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin), and cyclophosphamide (TAC), etc.) 5. Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted. 6. Concurrent use of hair growth products, such as Nutrafol, minoxidil, and Keranique. 7. A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up. 8. History of persistent alopecia (any grade) induced by prior chemotherapeutic regimens. 9. History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss. 10. Cold sensitivity. 11. Intercurrent life-threatening malignancy. 12. Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism. 13. History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia. 14. Concurrent hematologic malignancy. 15. Concurrent treatment with any investigational agent. 16. Any reason the investigator does not believe the patient is a good candidate for the study. 17. Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitant administration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.

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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.

Contacts and locations

Locations

  • University of California, San Francisco

    San Francisco, California, 94143, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.