Rare Disease Report

FDA Approves Expanded Use of Cooling Cap for All Solid Tumor Patients

JULY 03, 2017
James Radke
The U.S. Food and Drug Administration (FDA) has approved the expanded use of the DigniCap Cooling System to include patients undergoing chemotherapy for solid tumors. The cooling cap was first approved in 2015 to reduce hair loss in women with breast cancer undergoing chemotherapy.
Per the FDA: “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.”
Alopecia, or hair loss, is a common side effect of the chemotherapies often used to treat solid tumor cancers. Hair loss is usually temporary, but minimizing such side effects are considered important to overall treatment.
The DigniCap Cooling System circulates liquid to a cap in order to cool the scalp during chemotherapy treatment. The cooling constricts blood vessels in the scalp, thereby reduces the amount of chemotherapy that reaches hair follicles. The cold temperature also slows down cell division of the hair cells which makes them less affected by chemotherapy.
The FDA originally granted marketing authorization of the DigniCap for breast cancer patients based on a study comparing 106 women undergoing chemotherapy who wore the DigniCap compared to 16 women who did not. The scalp cooling system was worn during each chemotherapy session as well as 30 minutes before  and 90 – 120 minutes after the session; with a scalp temperature maintained at 3°C (37°F).
The study found hair loss of 50% or less occurred in 66% of the patients wearing the cap compared to 0% in in the control group. That study was published in JAMA earlier this year.
It is not clear what additional data, if any, the FDA examined to extend the use of the DigniCap for all solid tumor patients receiving alopedicia-associated chemotherapy.
The most common side effects of the cooling system include cold-induced headaches and neck and shoulder discomfort, chills and pain associated with wearing the cooling cap for an extended period of time.

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Image by Carolyn Dempsey who was using the DigniCap during treatment at Weill Cornell Medicine.  

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