NCT05484973 Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 99 participants in total. It began in 2024-11-08 with a primary completion date of 2026-03-31.

Brief Summary

The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

Eligibility Criteria

Inclusion Criteria: 1. Female patients ≥ 21 years of age 2. Documented diagnosis of breast cancer, stage I, II, or III 3. A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent 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. Plan to complete the current CT regimen within six months 6. At least two years out from the last CT causing hair loss with complete recovery of hair 7. Karnofsky17 performance status 80% or greater 8. Willing and able to sign informed consent for this study 9. Willing and able to complete all required study procedures 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 (AC/T, EC/T, TAC, etc.) 5. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted 6. Current and/or prior 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 grade 2 (or higher) alopecia 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. Participation in any other clinical investigation 16. Concurrent treatment with any investigational agent 17. Any reason the investigator does not believe the patient is a good candidate for the study

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