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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
99
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.
University of Arizona
Tucson, Arizona, United States
RECRUITINGCarle Health
Urbana, Illinois, United States
RECRUITINGHair 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.
Time frame: 3 Weeks
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.
Time frame: 3 Weeks
Scalp changes
Occurrence of scalp changes in patients during and after use of the AMMA PSCS.
Time frame: 3 Weeks
Patient symptoms
Patient symptoms reported during use of the AMMA PSCS as recorded by a symptom survey following each infusion session.
Time frame: 3 Weeks
Subject's tolerability
Subject's tolerability of AMMA PSCS treatment demonstrated by responses to questions related to tolerability.
Time frame: 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.
Time frame: 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
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Time frame: 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.
Time frame: 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.
Time frame: 3 Weeks