Can alopecia in women with breast cancer undergoing chemotherapy be minimized? That’s the question the Hair to Stay program seeks to answer in a study of scalp cooling, which represents the most potentially effective method of preventing hair loss, said Michelle Melisko, MD, University of California, San Francisco (UCSF), during the 33rd CTRC-AACR San Antonio Breast Cancer Symposium. As many as 8% of patients may decline chemotherapy if at risk for alopecia, and those with alopecia may have lower self-esteem, poorer body image, and lower quality of life.

Dr. Melisko and colleagues have initiated a pilot study of the Swedish DigniCap scalp cooling system (Dignitana, Lund, Sweden) to test its safety and effectiveness. Coolant is circulated inside a gel cap to cool the scalp while the patient is undergoing chemotherapy, leading to vasoconstriction. Caps are placed on the head 20 to 30 minutes prior to chemotherapy and are worn for up to 4 to 5 hours. Patients are currently being enrolled in the study at the UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, and at Wake Forest University Medical Center, Winston-Salem, North Carolina.

“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.”


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Historically, Dr. 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, she added, “the incidence of scalp metastases in breast cancer is extremely low, and we are carefully following patients using these systems.”

In addition to the DigniCap, two other cooling systems are available worldwide: Penguin Cold Cap Therapy (MSC, London, United Kingdom) and the Paxman Hair Loss Prevention System (Paxman Coolers Limited, Huddersfield, United Kingdom). Future directions include seeking US FDA approval and insurance reimbursement and ensuring broader patient access to and knowledge of cooling options, Dr. Melisko said. One recently formed advocacy group is The Rapunzel Project. “Hair to Stay” is being funded by the Laszlo N. Tauber Family Foundation.