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

Launched by COOLER HEADS CARE INC. · Jul 29, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special device called the Portable Scalp Cooling System (PSCS) can help prevent hair loss in women undergoing chemotherapy for early-stage breast cancer. The study aims to see how well the device works, whether it is safe to use, and how it affects the participants' quality of life and satisfaction with their hair preservation during treatment.

To participate, women need to be at least 21 years old and have a confirmed diagnosis of stage I, II, or III breast cancer. They should be planning to start a specific type of chemotherapy that includes certain medications, and they must not have had any previous chemotherapy that caused hair loss within the last two years. Participants will be required to follow specific guidelines and complete all study procedures. Throughout the trial, women can expect regular check-ins to monitor their experience and hair health while they undergo treatment.

Gender

FEMALE

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