Receiving CIA treatment with the PAXMAN Scalp Cooling System

No hair retention treatment

The Paxman Scalp Cooling System is a clinically proven medical device designed to prevent or reduce chemotherapy-induced alopecia (hair loss). It is FDA-cleared for use in patients with solid tumors, such as breast, ovarian, and prostate cancers.

To determine whether the PAXMAN Scalp Cooling System is effective for improving the quality of life of breast cancer subjects in the Appalachian Highlands region. The Self-Reported Alopecia (Hair Loss) Pictorial Tool will be performed to specifically evaluate hair retention and regrowth (on Day 1 and post-treatment 4 weeks (± 1 week), 8 weeks (± 1 week), and 12 weeks (± 1 week)). Grading will be for 0 to 2, with 0 being No Significant Hair Loss, 1 being Hair Loss up to 50%, and 2 being Hair Loss > 50% as judged by the participant (and referred to as self-reported).

To determine whether the PAXMAN Scalp Cooling System is effective for improving the quality of life of breast cancer subjects in the Appalachian Highlands region. The Chemotherapy-Induced Alopecia Distress Scale (CADS) will be used to evaluate quality of life on Day 1 and post-treatment 12 weeks (± 1 week). The CADS assesses the psychosocial impact of hair loss due to chemotherapy, helping to understand a patient's level of psychological distress. It specifically measures various aspects of a patient's well-being, including physical, emotional, activeness, and relationship distress. The CADS is a 17-item self-report questionnaire that uses a four-point Likert scale (0 = Not at All, 1 = A Little, 2 = Quite a Bit, 3 = Very Much). The total score can range from 0 to 51, with higher scores indicating greater distress. Scores from 0 to 13 indicate low levels of distress, while scores of 14 or above indicate a high level of distress related to chemotherapy-induced alopecia.

To determine the incidence rate and relevance of single nucleotide variations (SNVs) previously linked to CIA in Japanese and Spanish populations for the Appalachian Highlands region of the southeastern United States by sequencing analysis of rs3820706 in the CACNB4 gene and rs1202179 in the ABCB1 gene prior to chemotherapy treatment for all participants.