MedicalResearch.com Interview with:
Julie Rani Nangia, M.D.
Breast Center – Clinic
Baylor College of Medicine
Houston, TX, US
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study was fueled by the feedback from women undergoing chemotherapy treatment for breast cancer. One of the most distressing side effects of their treatment is hair loss. It robs them of their anonymity and, for many, their femininity. Scalp cooling therapy has been available for a few years in the UK, but has faced obstacles in FDA clearance in the states. The makers of the scalp cooling device used in this study, Paxman Coolers Ltd., have a personal connection to breast cancer, as the company founder’s wife passed away from the disease.
This was the first randomized scalp cooling study, and it shows that the Paxman Hair Loss Prevention System is an effective therapy for reducing chemotherapy-induced alopecia. The results show a 50% increase in hair preservation of grade 0 or 1, meaning use of a scarf or wig is not necessary, in patients who received the scalp cooling therapy as opposed to those who did not.
MedicalResearch.com: What should readers take away from your report?
Response: Readers should take away confidence in knowing there is a therapy out there that can help preserve their hair during chemotherapy treatment. We hope this study will provide a solid foundation for the argument to bring this technology to the US market. As the technology becomes more widely available and used, we anticipate the success rate could be even higher as best practices for cap fit and application are established.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: For future research, we will be looking at any long-term adverse effects and potential chances of scalp metastases. I would also love to look at the efficacy in stage 3 breast cancer as well as other solids tumors. We have still not been able to effectively evaluate the effects of chemotherapy induced alopecia on the psyche and I am working with others in the field to develop specific quality of life tools to better evaluate this. Additionally, we will continue to refine the application of the cap to ensure an even, tight fight around the scalp, allowing for maximum effectiveness.
MedicalResearch.com: Is there anything else you would like to add?
Response: No disclosures. We did receive institutional support to conduct the clinical trial. This research shows the impact a device like this can have. Paxman, the maker of the cooling cap system and funding organization for the study, has filed for FDA clearance and we are hopeful for a positive response.
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Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bågeman E, D’Agostino RB, Ver Hoeve ES, Esserman L, Cigler T. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer. JAMA. 2017;317(6):606-614. doi:10.1001/jama.2016.21038
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