The Food and Drug Administration (FDA) has expanded the use of DigniCap Cooling System (Dignitana, Inc.), to reduce alopecia during cancer chemotherapy. This approval marks the first cooling cap FDA-cleared for use in patients with solid tumors.

Alopecia is a common side effect of various chemotherapy regimens and is frequently associated with the treatment of most solid tumor cancers. The DigniCap Cooling System has been approved to reduce the frequency and severity of hair loss during chemotherapy in solid tumor cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used.

The cap is a computer controlled system worn on the head that circulates liquid to cool the scalp during chemotherapy. A secondary cap made of neoprene acts as an insulator to prevent loss of coolingand holds the cooling cap in place. The cooling constricts blood vessels in the scalp, reducing the amount of chemotherapy that reaches the hair follicles, and reduces the activity and cell division of the hair follicles making them less susceptible to chemotherapy. These two actions are thought to reduce the effect of chemotherapy on the cells, which may help reduce hair loss. 

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DigniCap was originally approved in 2015 for use in patients with breast cancer. This marketing authorization was based on a study of 122 women with Stage I and Stage II breast cancer undergoing chemotherapy particularly associated with hair loss. The study showed that over 66% of patients using DigniCap reported losing less than half their hair. To gain clearance for expanded use, the company submitted published, peer reviewed articles analyzing the use of DigniCap in patients with solid tumors other than breast cancer.

The device may not work with some chemotherapy regimens and is contraindicated in pediatric patients and patients with certain cancers. DigniCap may also not be appropriate for patients with cold sensitivities or susceptibility to cold-related injuries. Common side effects with the use of the cooling system include cold-induced headaches, neck and shoulder discomfort, chills, and pain associated with extended use of the cooling cap.

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