Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer, Early-stage Breast Cancer, Hair Loss, Alopecia, Chemotherapy-induced Alopecia

In brief

The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.

Key facts

Study ID

NCT06215469

Run by

University of California, San Francisco

People needed

40

Starts

2024-05-16

Expected to finish

2029-12-31

Last updated by the study team

2026-04-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically or cytologically confirmed breast cancer, stage I, II, or III.
• A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent.
• Plan to complete the current CT regimen within six months.
• 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.
• At least two years out from the last CT causing hair loss with complete recovery of hair.
• Age >=21 years
• Eastern Cooperative Oncology Group (ECOG) performance status of <=1.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale.
• Autoimmune disease affecting hair, e.g., alopecia areata, systemic lupus with associated hair loss, others.
• A history of whole brain radiation.
• 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.)
• Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted.
• Concurrent use of hair growth products, such as Nutrafol, minoxidil, and Keranique.
• A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up.
• History of persistent alopecia (any grade) induced by prior chemotherapeutic regimens.
• History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss.
• Cold sensitivity.
• Intercurrent life-threatening malignancy.
• Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism.
• History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia.
• Concurrent hematologic malignancy.
• Concurrent treatment with any investigational agent.
• Any reason the investigator does not believe the patient is a good candidate for the study.
• Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitant administration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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