comscoreFDA Approves Marketing of Paxman Scalp Cooling System in United States

FDA Approves Marketing of Paxman Scalp Cooling System in United States

The Paxman Scalp Cooling System has received FDA clearance.
Apr 20, 2017.This article is archived
We archive older articles so you can still read about past studies that led to today's standard of care.
Cold caps and scalp cooling systems are tightly fitting, strap-on, helmet-type hats filled with a gel coolant that’s chilled to between -15 to -40 degrees Fahrenheit. These caps and scalp cooling systems may help some women keep some or quite a bit of their hair during chemotherapy.
On April 19, 2017, the Paxman Scalp Cooling System received U.S. Food and Drug Administration (FDA) clearance. The Paxman System is made by the Paxman Company, which is based in the United Kingdom. FDA clearance means the Paxman Scalp Cooling System can be marketed in the United States.
This is the second scalp cooling system approved by the FDA. The DigniCap System was approved in December 2015.
Cold caps and scalp cooling systems 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 the follicles less affected by the chemotherapy medicine.
During each chemotherapy session, you wear the caps or scalp cooling system 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).
Cold caps and scalp cooling systems are slightly different. Cold caps are similar to ice packs. Kept in a special freezer before they’re worn, cold caps thaw out during a chemotherapy infusion session and need to be replaced with a new cap about every 30 minutes. Women usually rent the caps and the special freezer. Penguin, Chemo Cold Caps, and ElastoGel are some cold cap brand names.
With scalp cooling systems, such as the Paxman System, the cap is attached to a small refrigeration machine that circulates coolant, so the cap only has to be fitted once and doesn’t need to changed during chemotherapy. Scalp cooling systems are purchased by a cancer treatment center and people are charged to use the system while receiving chemotherapy.
The FDA based its clearance on a study that was presented at the 2016 San Antonio Breast Cancer Symposium. The study included 142 women diagnosed with stage I or stage II breast cancer. All the women were planning to have at least four cycles of either anthracycline- or taxane-based chemotherapy. Women treated with the TAC regimen, which includes both an anthracycline and a taxane, were excluded from the study. The women were randomly assigned to use the Paxman Scalp Cooling System (95 women) or no cooling (47 women). This was the first randomized study on scalp cooling to reduce or prevent hair loss during chemotherapy.
Women who used the scalp cooling system wore the cooling caps for 30 minutes before chemotherapy, during chemotherapy, and for 90 minutes after chemotherapy.
After four cycles of chemotherapy, photos were taken of the women’s scalps and an independent researcher evaluated the amount of hair loss.
Overall, about 50% of the women who used the scalp cooling system kept some or quite a bit of their hair and didn’t have to wear a wig to avoid looking bald. All the women who didn’t use the scalp cooling system lost more than 50% of their hair and had to wear a wig to avoid looking bald.
The type of chemotherapy regimen a woman received also affected the amount of hair preservation among women who used the cooling system:
  • About 65% of women treated with taxane-based chemotherapy lost less than half their hair; Taxol (chemical name: paclitaxel) and Taxotere (chemical name: docetaxel) are two taxanes commonly used to treat breast cancer.
  • About 22% of women treated with anthracycline-based chemotherapy lost less than half their hair; Adriamycin (chemical name: doxorubicin) and Ellence (chemical name: epirubicin) are two anthracyclines commonly used to treat breast cancer.
Common side effects of cold caps and scalp cooling systems are headaches and feeling cold while wearing them.
The most common side effects reported in the study were:
  • headaches
  • nausea
  • dizziness
Only one woman stopped using the cooling system while being treated with chemotherapy because she said the device was too cold.
“The women that wear the system describe it like jumping into a pool, where it’s very cold for the first 15 minutes, but then you get used to it,” said Julie Nangia, M.D., assistant professor of medicine at the Baylor College of Medicine who was the lead author of the study. “In our study, most women rated the device as being very or reasonably comfortable.”
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, where cold caps have been used since the 1970s, found that scalp cooling does not increase risk of scalp skin metastases, including a 2013 German study.
The cost of using the Paxman Scalp Cooling System is still being finalized, but in most cases a woman would be charged a fee each time the system is used. Cost estimates range from $1,500 to $3,000 for use during a complete course of chemotherapy. The Paxman Company said that it plans to install 250 systems across the country and is working to make using the system affordable.
If you’re interested in trying the Paxman Scalp Cooling System or another cooling system to preserve your hair during chemotherapy, 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 or scalp cooling systems 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 site for more information. Also, the Hair to Stay Foundation offers grants to pay for scalp cooling costs.
See what our Community members are saying about cold caps in the Discussion Board thread Cold Cap Users Past and Present, to Save Hair.
For more information on the Paxman Scalp Cooling System and the research that lead to its FDA clearance, listen to the podcast with Dr. Nangia, the lead researcher of the study.

— Last updated on February 22, 2022, 9:56 PM

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