Chilled caps could prevent baldness in cancer patients
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SAN FRANCISCO -- 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 blond 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, said Ms. Lisbon, of San Jose, Calif.
Now, Ms. 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," Hope Rugo, a physician at the University of California, San Francisco, said. "The psychological impact of hair loss, and the effect on work life, is significant."
More than 60 percent of the nation's 54,000 women with early-stage breast tumors will suffer total hair loss in chemotherapy, said Jennifer Obel, an oncologist at NorthShore University HealthSystem in Evanston, Ill.
Overall, about 900,000 cancer patients underwent chemotherapy in 2010, according to the American Society of Clinical Oncology in suburban Washington.
While patients who have used the scalp-cooling caps at UC San Francisco have retained most or all of their hair, Dr. 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 can't tolerate the cold caps; others have complained of headaches.
Ms. Lisbon said she has kept her hair after nine weeks of chemotherapy. The cap, used only during drug therapy, "offered the option of being private about going through aggressive cancer treatment," she said. "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."
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, Mr. Waleij said.
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, Mr. Waleij said.
The device is a tight-fitting, synthetic rubber cap connected to a control unit that 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 United States and Japan will be key to growth for the company, which has only one product, said Mr. Waleij, who declined to estimate U.S. sales.
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.
It is sold in Britain, Canada, Australia and New Zealand, 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.
Head-cooling devices have been used sporadically since the 1980s to prevent hair loss during chemotherapy, Dr. Rugo said. The newer cap being tested by Lisbon is a much improved version, she said.
Ms. Lisbon said that before learning about the DigniCap, she worried how people would react to her cancer.
"There is a stereotypical ideal of how cancer patients look," Ms. 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."
First Published January 30, 2011 12:00 am