The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.
PRIMARY OBJECTIVE: I. To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last chemotherapy (CT) treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) by comparing post-treatment photographs to pre-treatment photographs. SECONDARY OBJECTIVES: I. 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. II. To evaluate hair loss as measured by the patient at 3 weeks (±1 week) after the completion of the last treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE v5.0 or above) by comparing post-treatment photographs to baseline photographs. III. To assess tolerability/compliance with use of the PSCS. IV. To assess patient quality of life and satisfaction with hair preservation after Amma PSCS usage using the Body Image Scale (BIS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) for Breast Cancer (EORTC-QLQ-BR23) questionnaire. OUTLINE: Participants will use the AMMA PSCS while receiving non-investigational, chemotherapy treatments. Participants may continue device usage through their last cycle of chemotherapy (approximately 6 months) and will be followed for 30 days after the last device usage date, until removal from study, or until death, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
The unit is a compact, mobile refrigeration unit which circulates liquid coolant at low pressure through a special cooling cap on the participant's head, administered during non-investigational, cancer treatment.
Quality of Life (QoL) and device usage questionnaires
University of California, San Francisco
San Francisco, California, United States
RECRUITINGPercentage of participants with Grade 2 or lower hair loss
The percentage of participants with Grade 1 hair loss (defined by the NCI CTCAE as \<50% of normal for that individual that is not obvious from a distance but only on close inspection) with supported photographs of the scalp taken at baseline and 3 weeks after completion of last non-investigational CT treatment/ infusion for comparison and evaluation will be reported with a 95% confidence interval.
Time frame: Up to 7 months
Proportion of participants with device-related Adverse Events
The proportion of participants with any adverse events related to Amma PSCS device use, classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) and as reported in the Patient Symptoms and Tolerance Questionnaire
Time frame: Up to 7 months
Change in total score on the Body Image Scale (BIS)
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.
Time frame: Up to 7 months
Change in scores on the EORTC- QLQ-BR23
The EORTC-QLQ-BR23 is a questionnaire for measuring the quality of life in patients with breast cancer. Raw scores are computed but summing all items and then 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: Up to 7 months
Proportion of participants assessment of hair loss as <50%
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Participant 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 will be reported.
Time frame: At 3 weeks after completion of last CT treatment/ infusion