FDA Widens Access to 'Cooling Cap' to Stop Hair Loss in Cancer Patients

Treatment now OK'd for patients receiving chemotherapy for solid tumors

By Robert Preidt

Wednesday, July 5, 2017

WEDNESDAY, July 5, 2017 (HealthDay News) -- More cancer patients may be able to ward off hair loss during chemotherapy treatment.

A cooling cap approved in 2015 for use in breast cancer patients has won expanded approval from the U.S. Food and Drug Administration.

The DigniCap Cooling System can now be used for patients with solid tumors, the FDA announced.

The computer-controlled cap contains liquid that circulates and cools the scalp, narrowing blood vessels. This reduces how much of the chemotherapy drugs reach hair follicle cells, the FDA said.

Cooling also decreases activity of hair follicles and slows cell division. The result: Chemo drugs don't affect them as much, according to the FDA.

Hair loss is a common side effect of chemotherapy, especially during treatment of most solid tumor cancers. Hair may fall out all at once, little by little or become thin. It's usually temporary -- and upsetting.

"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," said Dr. Binita Ashar in an FDA news release.

Ashar directs the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health.

But the cap isn't for everyone. It may not work with some treatment regimens. And it should not be used on children, patients with certain cancers, and those having specific kinds of chemotherapy, the FDA said.

In addition, the agency said, the cap may be not be suited for patients with cold sensitivity or susceptibility to cold-related injuries.

Common side effects of the cap include cold-induced headaches, neck and shoulder discomfort, chills and pain. Wearing it is not likely to cause chemotherapy drugs to miss some cancer cells in the scalp, according to the FDA.

However, the long-term effects of scalp-cooling and risk of cancer spread have not been fully studied, the agency said.

SOURCE: U.S. Food and Drug Administration, news release, July 3, 2017

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