FDA Approves Marketing of DigniCap in United States

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Cold caps -- tightly fitting, strap-on hats filled with gel that’s chilled to between -15 to -40 degrees Fahrenheit -- may help some women keep some or quite a bit of their hair during chemotherapy.

Cold caps have been used in Europe since the 1970s, but until now, no cold cap has been approved by the U.S. Food and Drug Administration (FDA).

On December 8, 2015, the FDA approved the marketing of the DigniCap Scalp Cooling System in the United States. The DigniCap is made by Dignitana, a company based in Sweden.

Because they are so cold, cold caps work by narrowing the blood vessels beneath the skin of the scalp, reducing the amount of chemotherapy medicine that reaches the hair follicles. With less chemotherapy medicine in the follicles, the hair may be less likely to fall out.

The cold also decreases the activity of the hair follicles, which slows down cell division and makes them less affected by the chemotherapy medicine.

During each chemotherapy session, you wear the caps for:

  • 20 to 50 minutes before
  • during
  • after

each chemotherapy session. The amount of time you wear the cap after the chemotherapy session depends on the type of chemotherapy you’re getting.

The DigniCap System cap connects to a cooling/control unit that chills the cap to the proper temperature. Because the cap is chilled by the control unit, you don’t have to change caps during treatment as you do with some other caps that are chilled with dry ice.

The FDA based its approval on a study lead by Hope Rugo, M.D., clinical professor of medicine at the University of California, San Francisco. Dr. Rugo also is a member of the Breastcancer.org Professional Advisory Board.

In the study, 106 women diagnosed with either stage I or stage II breast cancer were prescribed chemotherapy regimens that were known to cause hair loss, mainly taxane chemotherapy with Taxol (chemical name: paclitaxel) or Taxotere (chemical name: docetaxel). The women wore the DigniCap during each chemotherapy cycle. There was also a similar group of women diagnosed with stage I or stage II breast cancer that were treated with the same chemotherapy regimens that didn’t wear the DigniCap.

Three to 6 weeks after the last chemotherapy cycle, standardized photos were taken of the women and they evaluated their own hair loss.

More than 66% of the women who wore the DigniCap System said they lost less than half their hair.

Common side effects of cold caps are headaches and feeling cold while wearing them.

The most common side effects reported in the study were:

  • cold-induced headaches
  • neck and shoulder discomfort
  • chills
  • pain from wearing the cooling cap for an extended period of time

Only three of the 106 women in the study stopped using the DigniCap because of side effects.

“Hair loss can be traumatic for many women with breast cancer because it reveals an illness that many would prefer to keep quiet,” said Dr. Rugo in an interview. “It’s such a marker for women -- for work, for their families, for their children -- that something’s wrong with them. You get just a few months of chemotherapy, and it takes more than a year for your hair to recover.”

It’s important to know that some doctors are concerned that the caps may prevent the chemotherapy medicine from reaching cancer cells that may be in the scalp. Many studies in Europe have found that scalp cooling doesn’t increase the risk of scalp skin metastases, including a 2013 German study. When announcing its approval, the FDA said the risk of scalp skin metastases was “extremely rare.”

It’s also important to know that cold caps may not work for everyone. Some European studies found that women who got only anthracycline chemotherapy had slightly better results with cold caps than women who got only taxane chemotherapy.

Adriamycin (chemical name: doxorubicin), Ellence (chemical name: epirubicin), and daunorubicin are anthracyclines.

Other European studies found that women who got both an anthracycline and a taxane in their chemotherapy regimen (combination chemotherapy), especially in combination with cyclophosphamide, seem to have the worst results with cold caps, though some of them still kept some of their hair.

The cost of using a DigniCap is still being finalized, but in most cases a woman would be charged a fee each time she used a DigniCap. Depending on how many cycles of chemotherapy a woman has, the total cost could range from $1,500 to $3,000 according to Dignitana Chief Operating Officer Bill Cronin. Dignitana is negotiating with insurance companies for coverage.

If you’re interested in trying the DigniCap System, talk to your doctor about all the factors that need to be taken into account, including your chemotherapy regimen and any other health issues you may have.

Women who use cold caps during chemotherapy are advised to baby their hair during treatment:

  • no blow drying, hot rollers, or straightening irons
  • shampoo only every third day with cool water and a gentle shampoo
  • no coloring until 3 months after chemotherapy is done
  • gentle combing and brushing

The Rapunzel Project is a nonprofit organization dedicated to helping women and men undergoing chemotherapy access and use scalp-cooling technology to help keep their hair. Visit the Rapunzel Project for more information.

See what our Community members are saying about cold caps in the Breastcancer.org Discussion Board thread Cold Cap Users Past and Present, to Save Hair.



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