This single-blind, randomized controlled trial is proposed to assess the effects of the PAXMAN Scalp Cooling System on the quality of life of breast cancer subjects receiving any treatment regimen consisting of a chemotherapy agent known to cause chemotherapy-induced alopecia (CIA). Quality of life will be measured using the Chemotherapy-Induced Alopecia Distress Scale (CADS) for cancer patients pre-and post-treatment. Simultaneously, the effect of scalp cooling on hair retention and regrowth will be determined by self-reported grading of photographic assessment using the Alopecia (Hair Loss) Pictorial Tool. Results will be correlated with presence of single nucleotide variations (SNVs) rs3820706 in the CACNB4 gene and rs1202179 in the ABCB1 gene. Participants will be blinded to genetic results until the completion of the study to prevent bias, as knowing results could influence the participants' behavior.
All patients with a diagnosis of stage I - III breast cancer, with planned therapy using any anthracycline- or taxane-based regimen.
Age ≥18 years
A documented informed consent will be obtained prior to inclusion in the study. All discussions with patients will be held in strictest confidence and out of earshot of the general public. Patients will be fully informed that their participation in the study is voluntary. Patients may decline to be part of the study. Their decision to participate in the study will not affect the care they receive.
Stage IV disease
Patients planning to shave their hair to the skin during chemotherapy treatment. Haircuts or trims will be permitted if they do not inhibit hair density analysis.
Intolerance to the PAXMAN Scalp Cooling System, including any contraindicated situations (i.e., hematological malignancies, cold urticarial, cold agglutinin disease, scalp metastases, any planned bone marrow ablation chemotherapy, and/or any skull irradiation).
Scalp lesions or pain that would be exacerbated by the PAXMAN Scalp Cooling cap.
Single group
Paxman Scalp Cooling System
DeviceThe 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.
Hair Retention and Regrowth
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).
Hair Retention and Chemotherapy-Induced Alopecia Distress
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.
Role of Single Nucleotide Variations
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.
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