Status:
RECRUITING
Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Cooler Heads Care Inc.
Conditions:
Breast Cancer
Early-stage Breast Cancer
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last chemotherapy (CT) treatment/infusion visit using the Common Terminolo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06215469
Start Date
May 16 2024
End Date
December 31 2025
Last Update
May 1 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143