A scalp-cooling device recently approved by the U.S. Food and Drugs Administration can prevent cancer patients from losing their hair during chemotherapy.
The new medical device was presented at the 2016 San Antonio Breast Cancer Symposium. The clinical trial was conducted in stage I and II breast cancer patients. It could be a solution to ease the emotional stress caused by hair loss in patients that also suffer stress caused by the disease itself.
“Patients and physicians have been hoping and searching for methods or therapies to prevent or reduce hair loss due to chemotherapy, but the options have been very limited due to the complexity of both the disease and the treatment,” said Julia Nangia, who led the research.
The Orbis Paxman Hair Loss Prevention System
The Hair Loss Prevention device has a two cap system. It was developed by Paxman Coolers LTD. It has an inner silicon cap whose function is to circulate refrigerated fluid and an outer neoprene cap that insulates the patient’s scalp. Both caps are meant to be worn during the course of the chemotherapy. The coolant maintains a consistent temperature by being connected to a small machine, which can be detached if the patient needs to move during the chemotherapy session.
Up until now, the device has been tested in 95 breast cancer patients, of which 48 (or 51%) kept a solid amount of hair by using the cooling cap even after four cycles of chemotherapy. On the other hand, none of the patients who were in the control group that did not use the cooling cap had hair after four cycles of chemotherapy. Therefore, this shows an incredible and positive result for the cooling system. The outcomes were presented at the San Antonio Breast Cancer Symposium. The company will receive funding to continue testing the product.
The objective of the cooling cap is to provide safety and efficacy while reducing hair loss. It has already been tested all over the United States including Cleveland Clinic, the Texas Oncology-Baylor Sammons Cancer Center, the Memorial Sloan-Kettering Cancer Center, the Texas Oncology-Medical City Dallas, among others.
FDA statement
Hair loss is a common side effect of certain types of chemotherapy, given the fact that this treatment destroys the cells of patients while trying to eliminate cancer. Patients may lose their hair entirely, gradually or partially, as well it can also get thinner and weaker. Though chemotherapy is important to fight cancer, it usually generates emotional side effects in patients.
The cooling system can reduce alopecia (loss of hair) during cancer treatment, and given the good results, the FDA has decided to approve it. It is intended to constrict blood vessels in the scalp, which should reduce the amount of chemotherapy reaching the cells in the hair follicles (hair roots).
“We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”
Source: Tech Times