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First Look: Cooling Cap Designed to Combat Hair loss Approved by FDA
by Matthew Dello Russo
On December 8th, the FDA announced its approval of the first cooling cap designed specifically to treat hair loss (alopecia) in female patients undergoing chemotherapy.
Hair loss is one of the most recognizable symptoms that plague chemotherapy patients. For many, it can be one of the most traumatic parts of treatment for an illness they’d rather keep private.
"It's such a marker for women — for work, for their families, for their children — that something's wrong with them," said Dr. Hope Rugo, the director of breast oncology at U.C.S.F. "You get just a few months of chemotherapy, and it takes more than a year for your hair to recover. “Hats are fine and good, but everyone knows you’ve lost your hair.”
With the introduction of the DigniCap, that may no longer be the case. The cooling cap, designed and manufactured by the Swedish company Dignitana, Inc., is a two-piece system regulated by a computer. The smart cap circulates a cooled liquid through the cap worn by patients during chemotherapy treatments.
In a recent study, Rugo and four other oncologists tested the DigniCap system on 122 women undergoing standard chemo regimens for breast cancer. More than two-thirds of the patients retained more than half of their hair during treatment.
The science behind the caps is relatively simple: when very cold agents (ie: the caps) are applied to an area, the blood vessels constrict. This process is called vasoconstriction, a mechanism by which the body regulates and maintains mean arterial pressure.
If the scalp is properly cooled (for both time and temperature), vasoconstriction stops the cancer-fighting drugs from reaching and damaging hair follicles in the treated area. Since caps are only applied to the scalp, the drug agents are able to work throughout the rest of the body without interference.
The idea of scalp cooling has been around for decades. Several different cold caps are sold throughout the world, but none have ever received FDA approval. In recent years, oncologists have seen breast cancer patients bring collections of gel-filled caps to their chemo sessions in large coolers, swapping out caps as they thaw.
With the FDA’s approval, DigniCap will be the first cooling cap system leased to cancer centers for regular use by patients undergoing chemo. While the cost of renting the caps is still being finalized, patients will be charged a fee for each use. According to Dignitana COO Bill Cronin, pricing would depend on the number rounds required, and the price could range anywhere from $1,500 to $3,000 total.
Common side effects include cold-induced headaches, neck or shoulder discomfort, and chills or pain through the scalp after extended use, the FDA said. It’s a small price to pay for the chance to avoid the hair loss experienced by many during standard chemotherapy treatments, according to medical oncologist Dr. Tessa Cigler.
"Being able to preserve one's hair during chemotherapy is very empowering,” Cigler says.
If you or someone you know would like more information about hair loss and how to treat it, please feel free to schedule a consultation or contact one of our representatives today!
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