Scalp Cooling System Shown to Reduce Hair Loss During Chemotherapy

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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 and -40 degrees Fahrenheit. These caps and scalp cooling systems may help some women keep some or quite a bit of their hair during chemotherapy.

A study has found that the Orbis Paxman Scalp Cooling System was safe and reduced severe hair loss by 50% in women diagnosed with stage I or stage II breast cancer who were being treated with chemotherapy.

Read the abstract of “Scalp cooling alopecia prevention trial (SCALP) for patients with early stage breast cancer.” The research was presented on Dec. 9, 2016 at the 2016 San Antonio Breast Cancer Symposium.

Cold caps have been used in Europe since the 1970s. On Dec. 8, 2015, the U.S. Food and Drug Administration (FDA) approved the marketing of the DigniCap Scalp Cooling System in the United States.

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 them less affected by the chemotherapy medicine.

Cold caps and scalp cooling systems are slightly different. Cold caps are similar to ice packs. Kept in a 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. Penguin, Chemo, and ElastoGel are some brand names.

With scalp cooling systems, the cap is attached to a small refrigeration machine that circulates coolant, so the cap only has to be fitted once. The scalp cooling systems, such as the Orbis Paxman System and the DigniCap System, are purchased by a cancer treatment center and people are charged to use the system while receiving chemotherapy.

With both types of cooling, you wear the cap for 20 to 50 minutes before receiving chemotherapy, while you’re receiving chemotherapy, and for a certain amount of time after the chemotherapy infusion is completed.

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 Orbis 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.

“This was an interim analysis,” said Julie Nangia, M.D., assistant professor of medicine at the Baylor College of Medicine who was the lead author of the study. “The trial stopped early because it was superior and very effective. In the scalp cooling group, 50.5% of the women retained their hair; we defined that as having less than 50% hair loss not requiring a wig. In the control group, nobody had hair retention, so it was a 0% success rate.

“The fit of the cap is very key, because if you don’t have proper fit of the cap, it doesn’t work,” she added.

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,” Dr. Nangia said. “In our study, most women rated the device as being very or reasonably comfortable.”

Dr. Nangia also said that preventing hair loss may improve women’s emotional well-being during chemotherapy and may allow them to maintain some privacy while undergoing cancer treatment. The women in the study will be followed for 5 more years to monitor overall survival, cancer recurrence, and any scalp metastases.

Paxman, the company that makes the Orbis Paxman System, is seeking FDA approval for the device. The process usually takes about 3 to 6 months. It’s not clear yet how much using the Orbis Paxman system will cost. The cost of using a DigniCap system ranges from about $1,500 to $3,000. It’s expected that pricing for the Orbis Paxman system will be similar. It’s also not clear if insurance will cover the cost of scalp cooling.

If you’re interested in trying a scalp cooling 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 with a history of migraines should not use scalp cooling systems.

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.

Listen to a Breastcancer.org podcast with Dr. Julie Nangia about her research on the Orbis Paxman Hair Loss Prevention System.

Editor’s Note: On April 19, 2017, the Paxman Scalp Cooling System received U.S. Food and Drug Administration clearance. This means the system can be marketed in the United States.


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