Study of the Paxman Scalp Cooling System to Improve Quality of Life and Hair Retention in Breast Cancer Patients Undergoing Chemotherapy and the Role of Genetic Variations in Hair Loss and Regrowth

What this Trial Is About

Researchers are evaluating the effects of the PAXMAN Scalp Cooling System on the quality of life of breast cancer patients receiving chemotherapy known to cause hair loss, called chemotherapy-induced alopecia CIA. This single-blind, randomized controlled trial will measure quality of life using the Chemotherapy-Induced Alopecia Distress Scale CADS before and after treatment. The study will also assess hair retention and regrowth through self-reported photographic assessments and explore genetic factors related to hair loss using specific single nucleotide variations SNVs. Participants will not know their genetic results until the study ends to avoid bias. The study involves 100 participants divided into two groups one group will use the PAXMAN Scalp Cooling System during chemotherapy to reduce hair loss, while the other group will receive no hair retention treatment. The device is designed to cool the scalp during treatment to help prevent or reduce hair loss. The study period includes treatment and follow-up lasting up to 12 weeks after chemotherapy ends. Participants will complete assessments of hair retention, hair regrowth, and distress related to hair loss from enrollment through 12 weeks post-chemotherapy. Genetic testing will be done to identify variations that may influence hair loss and regrowth. Researchers will monitor and record these outcomes to understand the impact of scalp cooling on quality of life and hair preservation during cancer treatment.

Evaluation of Scalp Cooling During Chemotherapy on Quality of Life and the Potential Role of Single Nucleotide Variations on Chemotherapy-Induced Alopecia and Hair Regrowth in the Appalachian Highlands Region