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Ice caps near FDA approval to prevent hair loss during chemotherapy

August 3, 2015

PITTSBURGH ó As a baby, Kim Nyalkaís now 7-year-old daughter would twist her fingers through her motherís hair as she fell asleep, and playing with her motherís hair is still a treasured habit.

So when Nyalka found out that sheíd have to have chemotherapy for breast cancer, she started first looking into wigs, and then into scalp cooling ó a treatment that uses cold caps on the head to prevent hair loss during chemo ó to make the process less traumatic for her family.

A year into her chemotherapy treatments, Nyalka, 47, of Whitehall, Penn., has indeed kept her hair. It has been a cumbersome process with each treatment requiring 80 pounds of dry ice, hundreds of dollars, hours of brutal cold and plenty of assistance from her husband, but for her itís been worth it.

"Itís really made this past year of treatment much less of an issue ó for me and for my family," she said. "Just for keeping normalcy in our family, not having her worry, and not having her be afraid."

Scalp cooling, which has not been widespread in most places in the U.S., may be on the verge of mainstream acceptance. One brand of the caps, DigniCap, is nearing approval by the U.S. Food and Drug Administration and will be available for use on a limited basis at Magee-Womens Hospital of University of Pittsburgh Medical Center once that approval comes through.

Nyalka has a brand called Penguin Cold Caps, invented in England about two decades ago and used in the U.S. for about 15 years. The devices are not FDA approved, so patients must rent them from the company and operate them themselves.

Chemotherapy works by attacking dividing cells, such as cancer cells, but also those in hair follicles. Scalp cooling constricts the blood vessels that lead to the hair follicles, reducing the amount of the chemo drugs that reach the follicles.

The manufacturer of Penguin Cold Caps says that the technology is effective in about 86 percent of patients, though that figure varies depending on the specific chemo drug. A five-year U.S. clinical trial of the DigniCap, released recently at the American Society of Clinical Oncology, found that the caps prevented hair loss in 70 percent of patients, versus the control group where 100 percent experienced significant hair loss.

In the U.S., only those enrolled in clinical trials have had access to DigniCaps. Thousands of people in the U.S. have used Penguin Cold Caps over the years, and about 350 are using them at any given time, though "in Pittsburgh the numbers appear to be lower than elsewhere," said Frank Fronda, the companyís inventor and director.

Nyalka has received chemo treatments at Allegheny General Hospital every three weeks for about a year. For each treatment, she and her husband pick up 80 pounds of dry ice from a facility in the area and load it into special coolers they purchased. The caps are rented from the company for about $600 per month, and must be cooled to a precise temperature ó minus 22 degrees Fahrenheit ó that is colder than standard freezers.

Her scalp must be pre-cooled by the caps before the chemotherapy begins, and the caps are left on during the therapy and for about 3 to 4 hours afterward. The caps also must be changed for a freshly cooled one about every half hour to maintain the correct temperature.

"When I first put them on, particularly during the first cooldown, itís so cold it hurts," said Nyalka, who wears heated blankets during treatments. "You sort of get used to it, and then it doesnít bother me as much."

In many other cities nationwide, the process is somewhat simpler. A Minneapolis-based foundation called The Rapunzel Project, which works to make scalp cooling easier for cancer patients, has donated medical freezers to dozens of cancer centers and hospitals around the country when the facility or a patient has requested them. Freezers, which eliminate the need for patients to purchase and manage dry ice, are available in Philadephia and Lancaster, Penn., but not in Pittsburgh.

When Nyalka brought up the caps with her doctor, he didnít discourage her from using them, but said he wasnít convinced of their effectiveness. Other doctors are more skeptical.

"I donít personally recommend or use them," said Helen Analo, an oncologist with Allegheny Health Network. "Itís uncomfortable, itís not that effective, and most women regain their hair anyway after chemotherapy."

Dr. Analo said that she has concerns about the possibility that the caps will create a "cancer sanctuary" in the scalp because the chemotherapy drugs are reduced there, citing two case reports of patients who have used scalp cooling who contracted cancer in the scalp years after treatment.

For Adam Brufsky, co-director of the comprehensive cancer center at Magee-Womens Hospital and the University of Pittsburgh Cancer Center, the recent DigniCap study presented at ASCO satisfied his concerns about the possibility of scalp cancer. The study found no evidence of an increase in scalp metastases in patients who have used scalp cooling.

He knows of UPMC patients who have "very very uncommonly" used cold caps over the years. "The older technology does work, but itís cumbersome and hard to use," he said.

The newer DigniCaps stay on the patientís head for the duration of the chemotherapy and do not need to be changed, keeping their temperature constant by circulating a cold gel through the cap.

Even after the likely FDA approval, they will be available on an extremely limited basis until the company perfects its technology and scales up production. Magee is likely to get only one unit at first, said Dr. Brufsky, which can be used by just two patients at a time.

At the same time, the impact on patients can be profound. "Weíre really making chemotherapy a lot easier on people," he said. "One of the biggest side effects is loss of hair. If this can address that, itís wonderful."

Newer companies, such as Dallas-based Chemo Cold Caps and the British Paxman Scalp Cooling, are also available for purchase or in clinical trials.

The effect of hair loss on cancer patients is about more than just vanity, said Nancy Marshall, co-founder of the Rapunzel Project, and a breast cancer survivor herself.

"If you have heart disease and you walk down the street no one knows. When you have diabetes no one knows ó your medical situation is your business. When you have cancer, itís everyoneís business." She cites the benefits on a patientís identity, privacy and empowerment that can come from preserving the hair during chemotherapy.

Nyalka is happy to have her daughter laugh about the "funny cap" she wears home from chemo treatments ó while still running her fingers through Nyalkaís hair. She is thankful that she was able to afford the caps and follow the protocol, and would like others to be able to share in that experience.

"I would love to see it more readily available to more women," she said. "They ought to at least know that you have a choice. Psychologically, it makes you feel like you have some control over something that has happened to you."

 

 


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