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

Summary

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.

Eligibility

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.

Conditions6

Locations1 site

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