Winston-Salem Journal (NC)
July 08--Keeping her hair during breast-cancer chemotherapy treatments wasn't a matter of life and death to Cheryl Cook, but it made enduring the physical and emotional rollercoaster more bearable.
Cook, 68, was one of 10 local women to participate in a 2011 feasibility study of a scalp-cooling device, called DigniCap, at Wake Forest Baptist Medical Center. That study featured 20 women nationwide.
The device, aimed at patients with stage I and II breast cancer, is in clinical use in Canada, Europe and Japan.
The success of the 2011 trials has led the Food and Drug Administration to recently approve Dignitana's request to conduct a second trial involving 110 patients and five sites, including at least 20 at Wake Forest Baptist. It could be the last clinical step toward achieving FDA clearance of the device.
DigniCap is a tight-fitting silicone cap placed directly on the head, with an outer neoprene cap that insulates and secures the inner one. The cap is connected to a cooling and control unit with touch-screen controls. The design leaves the ears uncovered.
"It was an absolute blessing given the timing of the clinical trial," said Cook, who has been cancer free since the treatments.
Hair loss has been an inevitable side effect caused by chemotherapy, said Dr. Hope Rugo, principal investigator for University of California at San Francisco.
"For many women, this is the most emotionally distressing and disturbing impact from their diagnosis," Rugo said. "A short course of chemotherapy results in total hair loss, taking many months to grow back."
According to Dignitana, more than 80 percent of the patients in non-U.S. clinical trials have kept their hair during chemotherapy.
Cook said she discovered the clinical trial online shortly after getting her treatment plan from Wake Forest Baptist physicians for her stage 1 breast cancer.
"They had told me to expect total hair loss by the end of the second of four treatments," Cook said. "After reading up on the study, I got in touch with the researchers the next day and was accepted into the program.
"To be given the chance to keep my hair made the chemo much more bearable, particularly because nobody had to know what I was going through."
Dr. Susan Melin, the lead Wake Forest Baptist study investigator, said it is "typically two of the first questions I get -- will I lose it, and when will I lose it?" Melin specializes in treating breast cancer as an associate professor of internal medicine in hematology and oncology.
"They feel like it is a declaration to the world of their condition and the chemo they're about to go through. Basically, the DigniCap would be used for certain patients who have a moderate chance of their cancer recurring," Melin said.
The cap works like this:
A coolant circulates throughout the inner silicone layer. The cap is designed to deliver consistent cooling to all areas of the scalp. The device features safety sensors that monitor and optimize the treatment temperature, typically around 42 degrees. A lower temperature is recommended for patients with thick hair.
When a cap is applied to the head, the temperature of the scalp is lowered over a 20- to 30-minute period. Blood vessels surrounding the hair roots contract, resulting in a significant reduction of cytotoxins to the follicle.
Reduced blood flow leaves a smaller amount of chemotherapy available for uptake in the cells. The decreased temperature results in less absorption of, and reduced effects from, the chemotherapy.
Cook said she had very little hair loss, "possibly because I had so much thick hair to begin with."
In fact, Cook's hair loss was so minimal she found herself needing a haircut before the third treatment to better fit the cap on her head.
Melin said there have been few side effects with the cap, primarily headaches. Some women who already had thin hair experienced more thinning.
Cooling systems and cold caps have not been used previously in the United States because of concerns that the scalp cooling could allow cancer cells to hide in the scalp.
"The incidence of scalp metastases in breast cancer is extremely low," Rugo said. "In a large review of published data on scalp-cooling systems, scalp metastases were not increased.
"We are carefully following patients using these systems in several clinical trials."
Cook said she's glad other local women will get to benefit from DigniCap.
"Hopefully, this device will help them avoid what already is a bad situation from feeling worse," Cook said.
(c)2013 Winston-Salem Journal (Winston Salem, N.C.)
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