LOUISVILLE — The treatment of early stage breast cancer has come a long way in the past few decades, both with success rate of therapy and quality of life in patients.

Chemotherapy is one of several adjuvant treatments often used after surgery to help clear the body of microscopic cancer cells that may have broken off from a tumor. In the 1970s, this was usually a year-long regimen — infusions twice a month for 12 months. Now, the most common types of early stage cancer — that which has not spread to other organs — can be treated with chemotherapy in as few as four treatments over several months.

Improvements to anti-nausea medication in conjunction with treatment, as well as growth factors to help keep white blood cells up, have meant that many more patients can even continue to work during treatment. And within the last few years, the use of optional medical equipment new to the U.S. has helped stop the hair loss that traditionally accompanies chemotherapy.

“‘Okay, you’ve told me I can work, you’ve told me the anti-nausea meds are very good, but I don’t want to lose my hair,’” Dr. Jeffrey Hargis, hematologist and oncologist with the Norton Medical Group in Louisville, said he hears from patients.

“That’s a very important quality of life — you’re carrying around a tag with you that says, ‘I’ve had breast cancer.’”


In 2015, Norton became the first medical group in the region to begin using the DigniCap — a scalp cooling device that helps prevent hair loss in patients undergoing chemotherapy — after it was approved by the Federal Drug Administration.

Patients purchase a cap kit, which is then hooked up to a machine at the infusion center to keep their heads cooled to 32 degrees Fahrenheit before, during and after chemotherapy. This helps prevent hair loss by putting hair cells into hibernation. Dignitana charges Norton $300 each time the machine is turned on, but the medical group pays $200 of this to help offset the cost to patients, Hargis said.

The treatment is not covered across the board by insurance, but some patients can submit claims on their own to their insurance companies.

Although the device had been used in Europe for years, to gain approval for use in the United States, it needed to pass a clinical trial — sponsored by Swedish company Dignitana, which makes DigniCap.

In the study of 117 women with stage I or stage II breast cancer, 101 used the cooling device and 16 in a control group used no device.

The study found that of those who used the DigniCap, 66.3 percent did not lose more than half their hair during chemotherapy. Six of the women reported adverse reactions — three with mild headaches, one with moderate headaches, one with skin pain and one with discomfort.

“Overall, the DigniCap Scalp Cooling System appeared to be safe and well tolerated with only mild discomfort associated with the scalp cooling and effective in reducing the likelihood of chemotherapy-induced alopecia,” according to a study summary.

Since 2015, competing scalp cooling cap Paxman has also been approved in the U.S. and in July 2017, both were approved for use with adult patients with solid tumors — women or men. According to their websites, DigniCap is available in 108 clinics in the U.S., Paxman in 136.


Chemotherapy works by killing rapidly multiplying cells, which is what cancer is. By adulthood, most normal cell reproduction is finished, exceptions being blood cells and hair.

“Our blood vessels are done, our muscles are done, our lungs are done, our kidneys are done,” Hargis said. “But we’re manufacturing hair all over our body every single day.”

Once the white blood cells were protected from the chemotherapy, the question remained — how can the hair follicles survive the treatment designed to kill them?

“The whole idea of scalp-cooling is based on the idea that if you cool the scalp adequately, you slow down cell division sort of by putting the cells into hibernation,” Hargis said. “It also causes blood [vessel] constriction, so there’s not as good of a blood supply to the skin.”

The oncologist said he’s been surprised to observe that with his patients, most women can lose half their hair and if fixed correctly, it’s not noticeable.

“So much so that the line I use is that if I was standing behind you in line at Kroger, I wouldn’t notice,” he said.


Louisville resident Vicki Graeter, one of Hargis’ patients, was diagnosed with breast cancer in April. She had surgery to remove the cancer, and has been undergoing chemotherapy for the past several months. After this, she’ll have 30 days of radiation.

Many women undergoing chemotherapy without cold caps are told to expect their hair loss within the first few weeks of their treatment. But Graeter had her fourth and final infusion at the end of September, and had lost only about half her hair.

Most of that she’s found as hair that came out in her hairbrush, just more than normal.

“But not clumps,” she said.

Graeter hadn’t been aware of the treatment until Hargis told her about it, as one option.

“I think I pretty much said [yes] right away,” she said. Graeter has a 5-year-old granddaughter, and she recalls telling her early in treatment that “‘Mimi might come out bald like your Pawpaw,’ And it kind of worried her.”

During office visits at the infusion center, Graeter first gets her lab work done. When that is cleared, a nurse starts getting her set up with the DigniCap, which has to be put on about 30 minutes before the chemotherapy is started. After the infusion is done, she keeps the cap on for another two hours. The entire process can be about five hours.

“It’s like a refrigerator on your head,” she said. “It can be a little painful in places, only for the first 30 minutes. You ever had a brain freeze? Kind of like that.”

But Graeter said she’s glad she has the opportunity to use the system.


Before DigniCap and Paxman were approved in this country, there were other cooling caps available, which work a little differently. Penguin, Chemo Cold Caps and ElastoGel have the same premise as the scalp cooling systems, but instead of being a machine which regulates temperature to the caps, patients need to have several frozen caps for each session, switching them every 20 to 30 minutes.

Hargis said while he’s seen success with patients who used the cold caps, they would often have sores from the cold. Added to that, it was a large endeavor that required the patient to bring a chest with dry ice and multiple family members to help get the thawing cap off and the new one on quickly enough.

“You had to bring a whole family,” Hargis said. “Very difficult to do if you just brought your sister or your daughter or your mother with you.”

Graeter is looking forward to her chemotherapy being finished. While she has missed only a week of work, right after her surgery, there’s still been fatigue after each chemo infusion, “like I’m walking up a hill everywhere I go,” she said.

Her husband, who’s sat with her throughout, is helping her get through it.

“He’s hanging in there with me,” she said.



For more information on one of the scalp cooling systems or scalp cooling caps, check the websites below:

• DigniCap, scalp cooling system approved in 2015 for use in the U.S., expanded use in 2017 for any adut patients with solis tumors. — https://dignicap.com/

• Paxman, scalp cooling system with expanded use in 2017 for any adult patients with solid tumors — https://paxmanscalpcooling.com/

• Penguin Cold Caps — https://penguincoldcaps.com/

• Chemo Cold Caps — http://chemocoldcaps.com/

React to this story: