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FDA Expands Use of Cooling Cap for All Solid Tumor Types


The FDA first authorized the use of Dignicap in April to thwart chemo-related hair loss in patients undergoing chemotherapy for breast cancer. The agency has now expanded the cap’s use to include patients with all types of solid tumors. The device circulates cool liquid to minimize the effects of chemo drugs on hair follicles.

Image courtesy of DigniCap

The U.S. Food and Drug Administration has authorized the use of a cooling cap to reduce hair loss associated with chemo therapy to include patients with all solid tumor types.

According to the FDA, which made the announcement in a news release earlier this week, the DigniCap cooling system is the first cap device to receive a broad indication for all tumors.

Chemo-related hair loss, also referred to as alopecia, is a common adverse event when treating solid tumors. While alopecia is usually temporary, it has an undeniable effect on patients with cancer.

“Managing the side effects of chemotherapy is a critical component to overall health and quality of life,” said Binita Ashar, MD, director of the FDA’s division of surgical devices in its Center for Devices and Radiological Health.

DigniCap now carries the FDA indication of reducing frequency and severity of chemo-related hair loss in patients with solid tumors when treatment regimens for these patients call for chemotherapeutic agents in doses known to cause alopecia.

The cap uses liquid to cool the scalp during chemotherapy. A second neoprene cap covers the liquid-circulating cap for insulation. A computer controls the circulation of the liquid. The FDA says that the cold liquid causes blood vessels in the scalp to constrict, which limits the quantity of chemotherapy drugs reaching hair follicles. The colder scalp temperature also slows cell division in hair follicles, also limiting their susceptibility to the drugs.

According to the American Journal of Managed Care, the FDA approved the use of DigniCAp in breast cancer patients in 2015. This authorization was the result of a study of 122 stage I and II female patients with breast cancer. These patients were receiving chemotherapy regimens known to cause alopecia. Of the patients who used the device, 66% reported losing less than half of their hair.

At the time, speaking on behalf of the American Cancer Society, Len Lichtenfeld, MD, deputy chief medical officer for the organization, said the decision to use DigniCap should be made in consultation with physicians administering chemotherapy.

“Women and their treatment team need to have a discussion about whether this device is appropriate for them based on what we know and don’t know about their use, and applying their own personal values to make a decision,” he said.

The FDA says that there is a rare chance that a chemotherapy drug could miss a small group of cancer cells in the scalp, due to the cooling action of the device.

“Long-term effects of scalp-cooling and risk of scalp metasis have not been fully studied,” the FDA says in its news release.

The device should not be used in pediatric patients with cancer, or in patients with certain types of cancers or in patients who are undergoing certain types of chemotherapy. Patients with cold sensitivity or “susceptibility to cold-related injuries,” should not use DigniCap, the FDA says.

Common adverse events from DigniCap include cold-induced headaches, discomfort in the neck and shoulder, and chills and pain that are the product of wearing the cap for an extended time.

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