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DigniCap Reduces Chemo Hair Loss, Gets FDA Approval

Update Date: Dec 11, 2015 12:43 PM EST

DigniCap is a new cap that will be given to women with breast cancer, who are going through chemotherapy. The Food and Drug Administration (FDA) announced Tuesday that it will market DigniCap in the U.S.

It brings down chemo hair loss or alopecia. Chemotherapy leads to hair loss, making the hair thin as well as fall out totally. Even though alopecia is only a "temporary side-effect" of cancer, the treatment necessitates preventing or reducing chemotherapy for overall treatment, according to a press release.

"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 Dr. William Maisel, FDA's acting director of the Office of Device Evaluation. "Managing the side effects of chemotherapy is a critical component to overall health and recovery."

DigniCap reduces hair loss as it cools the scalp, bringing down the temperature to a low level, which reduces blood flow, preventing chemotherapy from reaching the hair cells. This also makes the hair's cellular metabolism slower, preventing the hair from getting exposed to complete chemotherapy, according to manufacturer Dignitana.

The use of the cooling cap can induce side-effects such as headaches and discomfort in the neck and shoulders, due to the cold temperature and chills. Many patients wearing the cap for long periods also tend to feel the chills.

Still, there are sensors in the cap that can monitor the temperature, ensuring that the temperature does not dip below the freezing point during cancer treatment.

Oncologist Dr. Tessa Cigler from the Weill Cornell Breast Center was among the doctors involved in the trial. She agreed that DigniCap could, in fact, reassure women who tend to reject chemotherapy to agree to the treatment.

"Hair loss is probably the most dreaded of all the side effects of chemotherapy," she told ABC News. "There're women who refuse treatment because of hair loss. Being able to preserve one's hair during chemotherapy is very empowering."

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