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FDA Sanctions Cold Cap Hair Loss Prevention on Wider Range of Cancers

Cold cap devices which chill the scalp during cancer treatment in order to help reduce hair loss are to be offered to more and more patients in the US following a new government ruling.

The US Food and Drug Administration (FDA) has cleared a device named the DigniCap Cooling System for use on people with different types of cancer than those it is already cleared for.

The Dignicap Scalp Cooling SystemStudy on 122 women

Since 2015, DigniCap’s device has been cleared for use on patients with breast cancer following a study on 122 women with the disease who were undergoing chemotherapy. This study showed that two thirds of those who wore the device during treatment lost less than half of their hair.

In support of the expanded use of the device, DigniCap submitted evidence from published, peer-reviewed articles that analysed the application of the DigniCap to cancer patients with solid tumours in other areas of the body.

This data was deemed by the FDA to be sufficient scientific evidence to support the safety and efficacy of DigniCap for expanded use.

“We are pleased to expand the use of this product for cancer patients with solid tumours to potentially minimise 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.”

Total baldness possible

The side effects she mentions do include hair loss in a great many cases, as drugs designed to treat tumours are often unable to detect between healthy cells and cancerous ones and can cause damage to hair follicles, which leads to thinning. This can range from patchy hair loss to rather more severe shedding and even total baldness.

The cold cap chills the scalp to an optimal temperature to significantly reduce the flow of blood around that region. As the circulation reduces locally, so too does the likelihood that the cancer drugs will wreak havoc with the hair follicles, preventing hair fall. It can be a huge boon to people undergoing chemotherapy treatment, as when people are already feeling especially vulnerable and often physically weakened by their exposure to cancer drugs, the highly visible sign of losing their hair can often feel like the ultimate slap in the face.

The downside of cold caps is that they can be rather uncomfortable to wear due to the low temperatures involved, though few people seem to find them unbearable. There’s also no guarantee that hairloss won’t happen. Trials by UK company Paxman, however, have shown them to be very effective, and their own device – the Paxman Scalp Cooling System – claims an 89 per cent success rate on breast cancer patients.

When hair is lost to cancer drugs it usually grows back in a matter of months, though it can take up to a year for a full head of hair to properly regrow. A strange quirk of chemotherapy treatment is that hair quite often grows back slightly differently to how it was before – once-light hair can return slightly darker, and curls where hair used to be straight are common, too. Fortunately, this is usually only temporary, lasting around a couple of hair growth cycles.


The Belgravia CentreThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.


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