FDA Expands Approval of Cooling Cap

The US Food and Drug Administration recently expanded the use of the DigniCap Cooling System, which reduces hair loss during chemotherapy, to include patients with solid tumors.

The cap circulates liquid to cool the scalp and is held in place by a second cap that acts as insulation. The system reduces the frequency and severity of hair loss during chemotherapy by constricting blood vessels in the scalp, which decreases the amount of chemotherapy that reaches the cells of the hair follicles, and reduces activity of the hair follicles and slows down cell division.
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The efficacy of the DigniCap Cooling System was determined in a study that included 122 Stage 1 and Stage II women with breast cancer who were undergoing chemotherapy regimens that have been associated with hair loss. In the study, over 66% of patients who wore the DigniCap Cooling System while undergoing chemotherapy reported losing less than half of their hair. Additional studies showed that the DigniCap Cooling System reduced hair loss in patients with solid tumors in other areas of the body.

Common adverse effects included cold-induced headaches and neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time. However, the risk of a chemotherapy drug missing an isolated group of cancer cells in the scalp while patients wear the device is rare. The long-term effects of the device on the risk of scalp metastasis has not been fully studied.

In addition, the device is not recommended for pediatric patients, patients with certain cancers, and patients undergoing specific chemotherapy treatments. Patients with cold sensitivity or who are susceptible to cold-related injuries are not recommended to wear the device.

—Melissa Weiss


FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy [press release]. FDA. July 3, 2017. Accessed July 5, 2017.