Many men and women who undergo chemotherapy treatment say their largest issue is with losing their hair, and how to manage it so they do not look sick. Hair loss is a common side effect of certain types of chemotherapy, several of which are used in the treatment of mesothelioma. Now, thanks to a recent approval from the U.S. Food and Drug Administration, mesothelioma patients may no longer have to worry about this when it comes to their chemotherapy treatments.
Earlier this month, the FDA announced approval of the DigniCap Cooling System to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap for use by men and women cleared by the agency for use in cancer patients with solid tumors, according to a July 3 press release from the FDA. The cap had previously been approved for use with breast cancer patients.
“Scalp cooling is recognized around the world as a safe and effective therapeutic solution to one of the most traumatic side effects of chemotherapy,” said Johan Ericsson, Chief Executive Officer of Dignitana, the maker of the cap, in the company’s July 3 press release announcing the approval. “This FDA choice allows us to help even more patients in the U.S. as they navigate life with the disease.”
“Chemotherapy may ruin your cancer, but it doesn’t have to ruin your hair.”
The DigniCap website clarifies that cooling of the scalp has been proven to reduce alopecia due to chemotherapy. The company’s silicone cooling cap is a computer-controlled system connected to a cooling unit that circulates coolant through channels in the cap. The cooling is intended to constrict blood vessels in the scalp, which reduces the amount of chemotherapy that reaches cells in the hair follicles.
The 2015 approval by the FDA for breast cancer patients was granted after a study demonstrated that more than 66 percent of patients treated with the DigniCap reported losing less than half their hair. Dignitana subsequently submitted evidence supporting the use of the DigniCap on cancer patients with solid tumors in other areas of the body besides the breast. The FDA found “these studies provided valid scientific evidence to support the safety and efficacy of the expanded indication for the DigniCap.”
“We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” said Binita Ashar, M.D., director, Division of Surgical Devices, in the FDA’s Center for Devices and Radiological Health. “Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”
Often called asbestos cancer, mesothelioma is highly aggressive and is resistant to many standard cancer treatments. The average survival time varies from 4 – 18 months after diagnosis, but through aggressive treatment patients may increase their survival time. Chemotherapy is the primary treatment for most patients.
The DigniCap can be found at various cancer centers in New York including Weill Cornell Medicine, Memorial Sloan Kettering Memorial Hospital, and will soon be available at New York University Langone Perlmutter Cancer Center. To find out if the cap is available at your infusion center look for the locations where it is used.
To find out more about the DigniCap results see the Feb. 14 article in JAMA.
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