Portable scalp cooling system to prevent hair loss during chemotherapy
A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.
This study is testing if a portable cooling device can help women with early-stage breast cancer keep their hair while undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Cooler Heads Care Inc. Government |
| Drugs / interventions | trastuzumab, pertuzumab, radiation, cyclophosphamide, chemotherapy |
| Locations | 2 sites (Tucson, Arizona and 1 other locations) |
| Trial ID | NCT05484973 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate the effectiveness of the AMMA Portable Scalp Cooling System in preventing hair loss in women undergoing chemotherapy for early-stage breast cancer. Participants will be women aged 21 and older with stage I, II, or III breast cancer receiving a taxane-containing chemotherapy regimen. The study will assess not only the ability of the device to preserve hair but also its safety, tolerability, compliance, quality of life, and patient satisfaction. Data will be collected from electronic health records and through direct patient assessments during and after chemotherapy treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 21 and older with early-stage breast cancer who are scheduled to receive taxane-containing chemotherapy.
Not a fit: Patients with female pattern baldness or those who have not fully recovered from previous chemotherapy-induced hair loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for women undergoing chemotherapy by reducing hair loss.
How similar studies have performed: Previous studies on scalp cooling systems have shown promising results in reducing chemotherapy-induced hair loss, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tucson, Arizona and 1 other locations
- University of Arizona — Tucson, Arizona, United States (Recruiting)
- Carle Health — Urbana, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Kate Dilligan — Cooler Heads Inc.
- Study coordinator: Chris Schultz, BS
- Email: cschultz@ecr-inc.com
- Phone: 9715067552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.