Portable scalp cooling system to prevent hair loss during chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.