Approved: Possible Solution to Chemotherapy Hair Loss

Dignitana DigniCap Cooling System, to reduce hair loss in breast cancer patients, cleared for marketing by FDA

/ Author:  / Reviewed by: Jennifer Gershman, PharmD, CPh

(RxWiki News) Women facing chemotherapy for breast cancer may face another side effect: hair loss. But a new device could fight back.

The US Food and Drug Administration (FDA) Tuesday cleared the Dignitana DigniCap Cooling System for marketing. This device is meant to reduce hair loss in female breast cancer patients who are receiving chemotherapy.

“We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals,” said William Maisel, MD, MPH, acting director of the FDA's Office of Device Evaluation, in a press release. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”

Hair loss is a common side effect of chemotherapy. Chemotherapy is the use of targeted anti-cancer drugs, which can often be hard on the body. According to the FDA, chemotherapy-induced hair loss is particularly common in women with breast cancer.

So how does a cooling cap prevent chemotherapy-induced hair loss? The idea is that this cap cools the head, which constricts the scalp's blood vessels. This could reduce the scalp's exposure to harsh chemotherapy drugs in the blood stream.

This device, which comes from the Swedish company Dignitana, Inc., was studied on 122 women who were receiving chemotherapy for early-stage breast cancer. More than 66 percent of these women said they lost less than half their hair.

The women in this study reported side effects that included chills, pain, headaches and discomfort tied to wearing the device for an extended period.

The FDA noted that the benefits of improved patient self-image and quality of life likely outweigh the extremely small risk that cancer cells could be in the scalp and therefore protected by the DigniCap Cooling System.

Review Date: 
December 9, 2015
Last Updated:
December 9, 2015