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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Alopecia, Chemotherapy-induced Alopecia, Hair Loss, Breast Cancer

Intervention / Treatment
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* Device: AMMA Portalbe Scalp Cooling System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients ≥ 21 years of age Documented diagnosis of breast cancer, stage I, II, or III A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent 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 Plan to complete the current CT regimen within six months At least two years out from the last CT causing hair loss with complete recovery of hair Karnofsky17 performance status 80% or greater Willing and able to sign informed consent for this study Willing and able to complete all required study procedures Exclusion Criteria: Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others A history of whole brain radiation 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.) Hormone therapy concurrent with CT. Hormone therapy after CT is permitted Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss Cold sensitivity Intercurrent life-threatening malignancy Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia Concurrent hematologic malignancy Participation in any other clinical investigation Concurrent treatment with any investigational agent Any reason the investigator does not believe the patient is a good candidate for the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients will use AMMA<br>Device: AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia. | Device: AMMA Portalbe Scalp Cooling System<br>* AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Loss | To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last CT treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) post-treatment, by photographs, compared to baseline photographs. | 3 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related adverse events | To assess safety of the AMMA PSCS based on the occurrence of device-related adverse events, occurrence of scalp changes determined by physical examination, and patient symptoms with use of the PSCS. | 3 Weeks | 
| Scalp changes | Occurrence of scalp changes in patients during and after use of the AMMA PSCS. | 3 Weeks | 
| Patient symptoms | Patient symptoms reported during use of the AMMA PSCS as recorded by a symptom survey following each infusion session. | 3 Weeks | 
| Subject's tolerability | Subject's tolerability of AMMA PSCS treatment demonstrated by responses to questions related to tolerability. | 3 Weeks | 
| Patient assessment of hair loss | Patient assessment of hair loss as recorded in the Alopecia Self-Report Survey at post-treatment follow-up according to the following scale: <50% of normal for the patient, or ≥50% hair loss. | 3 Weeks | 
| Patient satisfaction and QoL - Body Image Scale (BIS) | Patient satisfaction and QoL as assessed by the BIS at baseline and posttreatment follow-up. The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 not at all to 3 very much). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance | 3 Weeks | 
| Patient satisfaction and QoL - European Organization for Research and Treatment (EORTC) QLQ-BR23 | Patient satisfaction and QoL as assessed by the EORTC's QLQ-BR23 at baseline and post-treatment follow-up. All scores are linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. A high QOL is represented by a high score for global health status or QOL. More severe symptoms or problems are represented by high symptom scores or items. | 3 Weeks | 
| Device success | Device success is defined as ability to set up and use the AMMA device as instructed. This will be measured for each treatment and then for all treatments. If a study subject does not complete one or more of the CT visits, that does not constitute a device failure. | 3 Weeks |