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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jan 10, 2024

Keywords

ClinConnect Summary

The Cooler Heads trial is looking at a special device called the Portable Scalp Cooling System (PSCS), which may help prevent hair loss in women undergoing chemotherapy for early-stage breast cancer. The study aims to find out if using this cooling system can help women keep their hair while they receive a specific type of chemotherapy that includes medications like paclitaxel or docetaxel. To be eligible for the trial, participants should be women aged 21 and older with confirmed early-stage breast cancer who are starting a taxane-containing chemotherapy regimen and haven’t had any hair loss from chemotherapy in the past two years.

If you join the study, you can expect to use the cooling device during your chemotherapy sessions. This is a post-market study, meaning the device is already available and is being tested in real-world conditions. It’s important to note that certain conditions, such as autoimmune diseases affecting hair or a history of specific types of hair loss, may disqualify someone from participating. This trial is currently recruiting participants, so if you're interested, please discuss it with your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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.