Jan. 25 (Bloomberg) -- Melissa Lisbon steeled herself for the nausea and bone pain tied to chemotherapy after being diagnosed with breast cancer. The possible loss of her shoulder-length blonde hair, though, made her anxious.
While the side effects of therapy can be shouldered privately, hair loss would be a blow to her ego and a visible signal that she is a cancer victim, the San Jose, California, woman said. Now Lisbon is among 20 patients testing a helmet-like silicone gel cap, made by Dignitana AB that’s designed to cool the scalp and keep her tresses intact.
“I’ve had patients who took longer to decide on doing chemotherapy due to concerns about losing their hair,” said Hope Rugo, a physician at the University of California, San Francisco, in a telephone interview. “The psychological impact of hair loss, and the effect on work life, is significant.”
More than 60 percent of the 54,000 women in the U.S. with early-stage breast tumors will suffer total hair loss in chemotherapy, said Jennifer Obel, an oncologist at NorthShore University HealthSystem in Evanston, Illinois, in a telephone interview. Overall, about 900,000 cancer patients underwent chemotherapy in 2010, according to the American Society of Clinical Oncology in Alexandria, Virginia.
While patients who have used the scalp-cooling caps at UC San Francisco have retained most or all of their hair, Rugo said more research is needed to assess safety and usefulness.
The Dignitana device cools the scalp to 41 degrees. One concern is that while this may keep chemotherapy’s poisonous effects from reaching hair roots, it also may allow stray cancer cells to remain in the scalp, she said. Some patients are unable to tolerate the cold caps while others have complained of headaches.
Lisbon, who asked that her age not be used, has kept her hair after nine weeks of chemotherapy, she said. The cap, used only during drug therapy, “offered the option of being private about going through aggressive cancer treatment,” she said in an interview.
“When you look in the mirror you look pretty much the same as you did prior to the treatment, and that goes a long way psychologically,” Lisbon said.
If the UC San Francisco study is successful, the company will begin a 100-patient study late this year, said Dignitana Chief Executive Officer Martin Waleij, whose company is based in Lund, Sweden. It hopes to get U.S. approval by the second half of 2012, Waleij said in a phone interview.
Sold in Europe
The product, called the DigniCap, is sold in Europe, generating $1 million in revenue in 2010, mostly in Denmark, Norway and Sweden. It may reach sales there of $4 million this year, Waleij said.
The device consists of a tight-fitting, synthetic rubber cap that’s connected to a control unit which circulates coolant through it, according to the company website. An elastic outer cap helps with insulation and ensures a tight fit. Circulation is controlled by temperature sensors and regulated by valves.
Gaining regulatory approval to sell the cap in the U.S. and Japan will be key to growth for the company, which has only one product, said Waleij, who declined to estimate U.S. sales. The company may seek a partner to help its marketing efforts in the U.S., he said.
Medical Specialties of California USA Inc., a closely held company now based in London, sells a similar device, called the Penguin Cold Cap, for reducing hair loss in cancer patients.
That product is sold in the U.K., Canada, Australia and New Zealand and isn’t approved in the U.S., said CEO Frank Fronda. The company aims to begin a clinical trial that would be needed to gain U.S. clearance, though it hasn’t yet filed an application to begin a study, he said. He declined to provide information on the company’s sales.
Used Since the 1980s
Different head-cooling devices have been used sporadically since the 1980s to prevent hair loss during chemotherapy, Rugo said. The newer cap being tested by Lisbon is a much improved version, she said.
Lisbon worked as an administrator in a law office before she was diagnosed. Now unemployed as she battles her disease, Lisbon didn’t hesitate to start chemotherapy because she wanted to be “cured once and for all.”
Before she learned about the DigniCap, she worried how people would react to her cancer.
“There is a stereotypical ideal of how cancer patients look,” Lisbon said. “I’m going through this treatment and it’s not so obvious to others. I feel like I’m in control of something.”
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To contact the editor responsible for this story: Reg Gale at Rgale5@bloomberg.net