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FDA Approves Cold Cap

Posted 12/9/2015

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  This is a "what goes around, comes around" story as there was another FDA approved cold cap about twenty years ago. What is a cold cap?, you might ask. It is a tight-fitting hat to wear during a chemotherapy infusion that is intended to reduce or eliminate hair loss. The theory is that the cold restricts blood vessels and blood flow to the scalp, so the drugs don't get there.

  Twenty or so years ago when an earlier version was briefly in vogue, there were three problems: It didn't work very well;it gave people intense headaches while and after they wore it, and some doctors worried about the diminished circulation of the drugs. As in, if you are going to agree to chemotherapy, don't you want to give it every chance to work? And might it be a problem to prevent the drugs from going to the scalp? Granted, scalp mets are rare, and the chemo does not cross the blood/brain barrier anyway (although there are a few new targeted drugs that do), so there is not a change to any penetration to the brain.

The trials of the cap have included women with Stage I or Stage II breast cancer. One would assume that the cap will work the same way for other people who receive other drugs, but that has not been tested yet.

The newly approved DigniCap seems to be much more comfortable to use, but I wonder about the third set of worries. I have known a few women who have tried it over the past year or so, and it seems to work variably. As you would guess, it works better for those drugs that cause hair-thinning, but do not necessarily cause total baldness than it goes for those drugs that leave you with a shiny, hairless head. There is also the issue of cost. As of now, I am aware of no insurance companies that will cover the cost. Looking at the company's website (, it looks as though they hope that cancer centers will purchase the caps and provide them to their patients. We will have to follow along to see if that happens.

  Here is an article from MedScape. I give you the start and a link to read more:

Cold Cap to Prevent Hair Loss During Chemo Cleared in US
Zosia Chustecka

Many cancer patients facing chemotherapy are aghast at the prospect of losing their hair, and for some years now in Europe and elsewhere there have been various scalp-cooling devices that promise to reduce this side effect.
Now the Food and Drug Administration (FDA) has cleared the first such device for marketing in the United States. The DigniCap Cooling System (manufactured by Dignitana Inc, in Lund, Sweden) has undergone a pivotal trial conducted at several centers in the US, and has been cleared for use to reduce hair loss in female breast cancer patients undergoing 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 Office of Device Evaluation in the FDA's Center for Devices and Radiological Health. "Managing the side effects of chemotherapy is a critical component to overall health and recovery."
Hair loss is a big deal for many patients. "For many women, this is the most emotionally distressing and disturbing impact from their diagnosis," said Hope S. Rugo, MD, professor of medicine at University of California San Francisco School of Medicine and lead investigator on the DigniCap study. "A short course of chemotherapy results in total hair
loss, taking many months to grow back," she told journalists earlier this year. Some women even think about skipping the chemotherapy "because it will adversely affect them at work when they lose their hair," she said.
DigniCap is a computer-controlled system that circulates cooled liquid to a cap worn on the head during chemotherapy treatment. The cooling cap is covered by a second cap made from neoprene, which fastens under the chin and holds the cooling cap in place. It also acts as an insulation cover to prevent loss of cooling, the agency explains.
The device is on show in the exhibition hall at the San Antonio Breast Cancer Symposium, which began today.
The cooling action is intended to constrict blood vessels in the scalp, which, in theory, reduces the amount of chemotherapy that reaches cells in the hair follicles. The cold also decreases the activity of the hair follicles, which slows down cell division and makes them less affected by chemotherapy. The combined actions are thought to reduce the effect chemotherapy has on the cells, which may reduce hair loss, the agency explains.


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