Portable scalp cooling system to prevent hair loss in breast cancer patients

Amma™ Portable Scalp Cooling System (PSCS) Study: A Post-market Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Early-stage Breast Cancer

This study tests if a portable cooling system can help women with early-stage breast cancer keep their hair while they undergo chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: trastuzumab, pertuzumab, chemotherapy, radiation, cyclophosphamide, doxorubicin
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06215469 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Amma Portable Scalp Cooling System (PSCS) in preventing hair loss in women undergoing chemotherapy for early-stage breast cancer. Participants will use the PSCS during their chemotherapy treatments and will be assessed for hair loss through photographic comparisons before and after treatment. The study also aims to evaluate the safety and tolerability of the device, as well as its impact on patients' quality of life and satisfaction with hair preservation. Follow-up will occur for 30 days after the last use of the device.

Who should consider this trial

Good fit: Ideal candidates include women aged 21 and older with confirmed early-stage breast cancer who are scheduled to receive taxane-containing chemotherapy.

Not a fit: Patients who are not undergoing chemotherapy or those with advanced-stage breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce chemotherapy-induced hair loss, improving the quality of life for breast cancer patients.

How similar studies have performed: Previous studies on scalp cooling systems have shown promising results in reducing hair loss during chemotherapy, indicating potential success for this approach.

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Jo Chien, MD — University of California, San Francisco
• Study coordinator: Ivy Ow

Conditions Breast Cancer; Early-stage Breast Cancer; Hair Loss; Alopecia; Chemotherapy-induced Alopecia; Hair Loss Prevention; Amma