Cornell: Scalp cooling can lessen some chemotherapy-induced hair loss – one of the most devastating hallmarks of cancer – in certain breast cancer patients, according to a new multicenter study from UC San Francisco, Weill Cornell Medicine, NewYork-Presbyterian and three other medical centers. A majority of the study’s patients, all women with stage 1 or 2 breast cancer who underwent scalp cooling, retained more than half of their hair after completing chemotherapy, the investigators learned. The study, published which tracks patients over five years, used standardized photographs to grade hair loss. The study was published Feb. 14 in JAMA, the Journal of the American Medical Association.
loss is almost universal among breast cancer patients receiving
adjuvant chemotherapy and is one of the most distressing of adverse side
effects,” said first author Hope S. Rugo,
MD, the corresponding author who led the study. Rugo is a UCSF
professor of medicine specializing in breast cancer research and
treatment, and director of the breast oncology and clinical trials
education program at the UCSF Helen Diller Family Comprehensive Cancer
found that scalp cooling during commonly used chemotherapy regimens was
well tolerated and was associated with significantly less hair loss, as
well as improvement in several quality-of-life indicators,” Rugo said.
“While further research is needed, the data suggest that when scalp
cooling is successful at decreasing hair loss, it could improve the
treatment experience for women undergoing adjuvant chemotherapy for
early-stage breast cancer.”
Breast cancer is the most common
cancer in women around the world, both in developed countries and less
developed ones, according to the World Health Organization.
cooling has been used in more than 30 countries as a way to potentially
prevent hair loss in patients receiving chemotherapy; in Europe it’s
been used for several decades. Two types of cooling caps are typically
used: frozen caps that need to be replaced every half hour, or cooling
systems that continually circulate coolants into a cap during the entire
Scalp cooling is thought to reduce hair
loss due to reduced delivery of chemotherapy to the scalp and hair
follicle, Rugo said. The cold temperatures also are thought to slow the
hair follicle cell division, making the cell less susceptible to the
damaging effects of chemotherapy.
In the United States, scalp
cooling has been limited because of factors including insufficient
scientific data and concern about the theoretic risk of scalp
For the JAMA study, researchers investigated the effectiveness of one device: the DigniCap
scalp cooling system manufactured by the Swedish public company
Dignitana AB, which partly funded the research. In December 2015, based
on preliminary results from the study, the U.S. Food and Drug
Administration cleared the DigniCap for use in the U.S., the first and
only cooling cap to date to receive such clearance.
In the JAMA paper,
122 women with stage 1or stage 2 breast cancer were studied – all
received non-anthracycline adjuvant chemotherapy, which generally causes
severe hair loss. Of those women, 101 were enrolled in scalp cooling;
16 others, also undergoing chemotherapy but not scalp cooling, were in
the control arm.
Scalp cooling began 30 minutes prior to each
chemotherapy cycle and involved a close fitting of the silicone cap on
the patient’s head, followed by an insulating neoprene cap. The silicone
cap was then gradually cooled. The DigniCap is set to cool at 3 degrees
Celsius (37 degrees Fahrenheit) with a temperature variance of plus or
minus 2 degrees.
Of 101 patients who underwent scalp cooling, 67
of them (66.3 percent) retained half or more of their hair, the authors
wrote. In the parallel control group, all the patients lost their hair.
Additionally, three of five quality-of-life measures were significantly
better for the women who underwent scalp-cooling, including feeling more
“Enabling a woman to preserve her hair during chemotherapy is empowering,” said senior author Tessa Cigler,
MD, MPH, an assistant professor of clinical medicine in the Weill
Cornell Breast Center and a member of the Sandra and Edward Meyer Cancer
Center at Weill Cornell Medicine, and an oncologist at
NewYork-Presbyterian/Weill Cornell Medical Center. “Scalp cooling allows
patients to protect their privacy and maintain their self-esteem and
sense of well-being. This study provides long-awaited evidence for an
effective and practical scalp cooling method.”
The mean age of the
cold cap patients was 53 years. Some 77 percent of the patients were
white, 9 percent were black and nearly 11 percent were Asian. The study
was conducted between August 2013 and October 2014. The average duration
of chemotherapy was 2.3 months.
Many of the patients reported
mild headaches or scalp pain associated with the scalp cooling. Two
patients discontinued scalp cooling due to feeling cold. There has been
no evidence of scalp metastases in any patient after approximately 30
months of follow up. All patient follow up will continue for a total of
The study was funded partially by the Lazlo Tauber
Family Foundation (awarded to UCSF); the Anne Moore Breast Cancer
Research Fund (awarded to Weill Cornell Medicine); and the Friedman
Family Foundation (awarded to Mount Sinai Beth Israel). Dignitana AB
supported the design and conduct of the study, including collection,
management, analysis and interpretation of the data.
co-authors also included researchers from the Icahn School of Medicine
at Mount Sinai, New York; Wake Forest Baptist Health Medical Center; and
the Jonsson Comprehensive Cancer Center at UCLA. From UCSF, co-authors
are Michelle E. Melisko, MD, and Laura Esserman, MD, MBA; from Weill Cornell Medicine, Anne Moore, MD, was also a co-author. A complete list of authors can be found in the paper.