Clinical trial NCT05484973: Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alopecia
Chemotherapy-induced Alopecia
Hair Loss
Breast Cancer
Lead sponsor: Cooler Heads Care Inc.
Sponsor class: OTHER_GOV
First posted: 2022-08-02
Enrollment: 99
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This is a prospectively enrolling, post-market, on-label study to assess the ability of the AMMA PSCS to prevent hair loss in women receiving CT for early-stage breast cancer, and to assess the safety, tolerability and compliance, patient quality of life, and satisfaction with hair after treatment. Female patients at least 21 years of age with stage I, II, or III breast cancer who are receiving a taxane-containing CT regimen that is scheduled to be completed within six months will be identified and data from the electronic health record (EHR) as well as prospective data will be collected.

AMMA is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home. Patients will participate in training in AMMA use and will be asked to bring the device to the chemotherapy infusion center for use during each chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy and for at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and after the last chemotherapy 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

Primary outcomes:
measure: Hair Loss
timeFrame: 3 Weeks
Secondary outcomes:
measure: Device-related adverse events
timeFrame: 3 Weeks
measure: Scalp changes
timeFrame: 3 Weeks
measure: Patient symptoms
timeFrame: 3 Weeks
measure: Subject's tolerability
timeFrame: 3 Weeks
measure: Patient assessment of hair loss
timeFrame: 3 Weeks
measure: Patient satisfaction and QoL - Body Image Scale (BIS)
timeFrame: 3 Weeks
measure: Patient satisfaction and QoL - European Organization for Research and Treatment (EORTC) QLQ-BR23
timeFrame: 3 Weeks
measure: Device success
timeFrame: 3 Weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Urbana
country: United States
facility: Carle Health
state: Illinois
Study officials:
affiliation: Cooler Heads Inc.
name: Kate Dilligan
role: PRINCIPAL_INVESTIGATOR
References: