FDA Expands Clearance for Cooling Cap Use With Chemotherapy for Solid Tumors

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The DigniCap Cooling System, cleared by the FDA for use in 2015, has also proved effective for cancer patients with solid tumors.
The DigniCap Cooling System, cleared by the FDA for use in 2015, has also proved effective for cancer patients with solid tumors.

The US Food and Drug Administration (FDA) granted clearance for expanded use of DigniCap Cooling System, a cooling cap to reduce hair loss (alopecia) to include cancer patients with solid tumors. The FDA had previously cleared the device for use just in patients with breast cancer in 2015.

Alopecia is a common side effect of chemotherapy and is observed frequently in the treatment of most solid tumor cancers.

Circulating liquid within the cap works to cool the scalp during chemotherapy. The cooling effect causes vasoconstriction, inhibits the activity of hair follicles, and also slows down cell division, decreasing both delivery and effect of chemotherapy on the scalp.

The FDA based its clearance on manufacturer-submitted evidence that demonstrated the effectiveness of the cap in preventing alopecia in patients undergoing chemotherapy. In a previous study, 66% of patients with breast cancer reported losing less than half of their hair. Additional studies which looked at the efficacy of the cap in solid tumors other than breast cancer supported the previous findings.

Binita Ashar, MD, the director of the Division of Surgical Devices from the FDA's Center for Devices and Radiological Health said of the clearance, “We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss. Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”

The cap is contraindicated in patients with certain cancers and specific chemotherapy treatments, as well as pediatric patients. Common side effects include chills and pain associated with wearing the cap, cold-induced headaches, and neck and shoulder discomfort. 


1. FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy [news release]. Silver Spring, MD: US Food and Drug Administration; July 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565599.htm. Accessed July 3, 2017. 
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