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Hair Loss News Archives
December 2010
UCSF tests promising solutions for cancer hair loss
Devices that prevent hair loss have the potential to make a huge difference to our patients
Dec 2010
UCSF physicians are combating a devastating side effect of
chemotherapy with an innovative new program -- "Hair to Stay" -- to
evaluate devices that could reduce scalp hair loss in breast cancer
patients.
One feasibility study on a scalp cooling system, the first
significant inquiry of its kind in the United States, will test the
safety and effectiveness of a device already widely used overseas
called the "DigniCap."
The FDA recently approved a pilot study of
the Swedish cool cap, which continuously cools a patient's scalp
during treatment using a circulating coolant inside a gel cap. The
first patients are being enrolled at the UCSF Helen Diller Family
Comprehensive Cancer Center and at Wake Forest University Medical
Center.
"Devices that prevent hair loss have the potential to make a huge
difference to our patients," said Laura Esserman, MD, MBA, co-leader
of the Breast Oncology Program at the center and director of the
UCSF Carol Franc Buck Breast Care Center. "If we can avoid hair
loss, then our patients can avoid one of the most emotionally
difficult and dreaded side effects of chemotherapy."
The cool cap process is a relatively simple and low-cost solution.
By cooling the scalp, blood vessels surrounding the hair roots
contract, resulting in a significant reduction of cytotoxins to the
follicle. With reduced blood flow, less chemotherapy is available
for cell uptake, while at the same time the lower temperature
results in less absorption of the chemicals.
UCSF breast cancer patients ineligible for the FDA DigniCap trial
have other scalp-cooling options. As part of another study
evaluating patient experience, the university has purchased a
freezer for cold caps, allowing patients to bring in their own caps
and keep them cooled during chemotherapy. Currently, patients who
provide caps go through as many as a dozen during a treatment
session -- the caps heat up in as little as 20 minutes.
Chemotherapy-caused hair loss takes a profound physical and
psychological toll on cancer patients and is considered one of the
most feared and traumatic side effects of cancer treatment.
"Almost all standard chemotherapy treatments for early stage breast
cancer cause hair loss," said Hope S. Rugo, MD, principal
investigator for the study and director of Breast Oncology and
Clinical Trials Education at the UCSF Helen Diller Family
Comprehensive Cancer Center.
"Every day, I sit across from women with a breast cancer diagnosis
for whom the inevitability of losing their hair is a painful and
emotionally distressing prospect. By helping to identify devices
that can reduce hair loss, we have the potential to impact patients'
quality of life."
Historically, Rugo said, cooling systems and cold caps have not been
used in the United States because of concerns that the scalp cooling
could allow cancer cells to hide in the scalp. But, Rugo said, "the
incidence of scalp metastases in breast cancer is extremely low and
we are carefully following patients using these systems."
The goal of the new feasibility study – the first step toward FDA
product approval – is to test how well patients tolerate the device,
invented in the 1990s by a Swedish oncology nurse.
In the study, a tight-fitting silicone cap is placed directly on the
head; an outer neoprene cap is placed on top to insulate and secure
the inner cap. Both are connected to a cooling and control unit with
touch screen controls. A coolant circulates throughout the inner
silicone layer, delivering consistent cooling to the entire scalp.
Following the feasibility study of 20 patients, a larger study of
100 patients is planned, an example of UCSF's commitment toward
accelerating the translation of cutting-edge research into advances
in patient care.
According to research by Dignitana, makers of the DigniCap system, 8
out of 10 women in Europe and Asia who used the company's cap
cooling system during chemotherapy retained their hair.
"The DigniCap system has been extremely well received in clinical
trials at leading medical centers around the world," said Chief
Executive Officer Martin Waleij. "We are very pleased that UCSF is
conducting this test so that cancer patients in the United States
might benefit as well."
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