Cool cap could keep hair on during chemo
NCT ID NCT06215469
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
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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
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2029
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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21 years and older
- Sex
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Anyone
- 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. 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
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University of California, San Francisco
San Francisco, California, 94143, United States
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Other studies related to the condition(s) this trial covers.
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